MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for UNKNOWN NCB PLATING SYSTEM TRAUMA N/A manufactured by Zimmer Gmbh.
[89014516]
The manufacturer did not receive x-rays for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89014517]
It was reported that the patient was implanted a ncb plating system trauma impl on the left side on (b)(6) 2017 and the patient underwent revision surgery on (b)(6) 2017 due to postoperative infection.
Patient Sequence No: 1, Text Type: D, B5
[114566454]
Investigation results were made available. As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive additional information for this case. The missing information was requested at complainant the latest one on (b)(6) 2017 but was not available. Trend analysis: no trend analysis could be performed as no item number(s) is/are available. Dhr-review: as no lot number was provided, the device history records could not be reviewed. The missing device information has been requested but was not available. At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. Event description: it was reported that a patient was implanted with an ncb femoral plate on (b)(6) 2017 on the left hip side and experienced postoperative infection. During latest debridement section, the fracture situation was found instable and therefore patient underwent revision surgery on (b)(6) 2017. Review of received data: the surgical report dated (b)(6) 20174 and dated (b)(6) 2017 were received. The surgical report dated (b)(6) 2017 is related to the plate breakage which is considered in complaint (b)(4). The review of that surgical report will be done during the investigation of complaint (b)(4). However, the surgical report dated (b)(6) 2017 describes that an ncb plate was implanted on (b)(6) 2017 and that the patient experienced post-operative infection. During latest debridement section, the fracture situation was found to be instable and therefore patient underwent revision surgery on (b)(6) 2017. The plate was replaced with a new ncb plate. Devices analysis: no product was returned to zimmer biomet for in-depth analysis. It was reported that device location is unknown. Review of product documentation: no medical data such as x-rays, surgical notes or any other case? Relevant documents were received. Root cause analysis: root cause determination using rmw: adverse body reaction due to cross contamination. => possible, it is possible that in the hospital a cross contamination did occur. Adverse biological reaction due to manufacturing residuals. => not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment. Adverse biological reaction due to chemical / galvanic / crevice corrosion of material. => not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment. Malpositioning of the implant due to inadequate implant design results in non-fitting of the plates to the bone. => not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment. Failure of surgery due to wrong selection of components or use in combination with device outside the system. => possible, it is possible that the user did not use components within the ncb system or did a wrong selection which may could have led to the instability of the plate. Failure of surgery due to use of the device not compliant with defined indications. => possible, it is possible that the use of the devices were not compliant with defined indications. Failure of surgery due to missing/incomplete information available, misleading information of surgical technique or instruction of use. => not possible -> no issue in the surgical technique. Failure of surgery due to wrong/misleading information of labels. => not possible -> no issue with labels. Failure of surgery due to insufficient warning of side effects. => possible, it is possible that the patient was not informed about post-operative restrictions. Conclusion summary: it was reported that a patient was implanted with an ncb femoral plate on (b)(6) 2017 on the left hip side and experienced post-operative infection. During latest debridement section, the fracture situation was found to be instable and therefore patient underwent revision surgery on (b)(6) 2017. The plate was removed and replaced with a new ncb plate. The removed ncb plate was not returned for product investigation, therefore the condition of the plate is unknown. The surgical report of implantation dated (b)(6) 2017 was not received. No intra-operative or post-operative x-rays have been received after the ncb plate implantation (b)(6) 2017. In conclusion, due to significant lack of information, a specific root cause for the infection and instable fracture situation cannot be determined. Note: plate breakage mentioned above is covered in complaint (b)(4). The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0009613350-2017-01398 |
| MDR Report Key | 6928021 |
| Date Received | 2017-10-09 |
| Date of Report | 2018-03-21 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2018-03-07 |
| Date Added to Maude | 2017-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN NCB PLATING SYSTEM TRAUMA |
| Generic Name | UNKNOWN NCB PLATING SYSTEM TRAUMA |
| Product Code | KPI |
| Date Received | 2017-10-09 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-10-09 |