MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-06-14 for UNKNOWN SIDUS COMPONENT N/A manufactured by Zimmer Gmbh.
[111002176]
The manufacturer did not receive devices for review. X-rays or other source documents were not provided for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. Additional information has been requested and is currently not available. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111002177]
It was reported that the patient was implanted unknown sidus components and underwent revision surgery due to implant failure. No further information is available at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00624 |
| MDR Report Key | 7600302 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-14 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2014-01-13 |
| Date Added to Maude | 2018-06-14 |
| 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 | 3 |
| Brand Name | UNKNOWN SIDUS COMPONENT |
| Generic Name | N/A |
| Product Code | PKC |
| Date Received | 2018-06-14 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| 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 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-14 |