MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2015-06-09 for BIOLOX DELTA CER HEAD 36 12/14 00-8775-036-03 manufactured by Zimmer Gmbh.
[5905686]
It is reported that the patient was implanted a biolox delta cer head 36 12/14 on an unknown date. It is now reported that the patient is experiencing unknown discomforts. No further details are known at that stage.
Patient Sequence No: 1, Text Type: D, B5
[13321969]
The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained for the information provided. Should additional information become available and an investigation result be available, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62585182]
Additional information received on 08/04/2015. Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted device(s) were received; therefore the condition of the component(s) was unknown. Patient factors that might affect the performance of the components such as bone quality, activity level, type of activity (low impact vs high impact), and relevant medical history were unknown. Adherence to rehabilitation protocol was unknown. In conclusion, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event. However, the possible causes are covered in the dfmea of the reported device. Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced. 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 | 9613350-2015-00650 |
| MDR Report Key | 4834266 |
| Report Source | 04,CONSUMER |
| Date Received | 2015-06-09 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-05-19 |
| Date Mfgr Received | 2015-08-04 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2015-06-24 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOLOX DELTA CER HEAD 36 12/14 |
| Generic Name | BIOLOX DELTA CERAMIC FEMORAL HEAD |
| Product Code | EML |
| Date Received | 2015-06-09 |
| Catalog Number | 00-8775-036-03 |
| Lot Number | 2552369 |
| Device Expiration Date | 2015-06-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-09 |