MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-09 for FEMORAL HEAD STERILE PRODUCT N/A 00801803602 manufactured by Zimmer Manufacturing B.v..
[174272048]
(b)(4). Concomitant medical products: zimmer head cat#00801803602 lot#63135590, zimmer liner cat#00630505036 lot#61049361, zimmer cup cat#00620205222 lot#61132699, zimmer stem cat#00771300700 lot#60825861, zimmer neck cat#00784803300 lot#62124936. The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018? 03906, 0002648920 - 2020 - 00021.
Patient Sequence No: 1, Text Type: N, H10
[174272049]
It was reported patient underwent hip revision due to osteolysis and necrosis. During revision fluid, osteolysis, necrosis, and metallosis were noted. Liner and head were removed and replaced. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00021 |
| MDR Report Key | 9568554 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-04 |
| Date of Event | 2016-05-18 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2015-08-19 |
| Date Added to Maude | 2020-01-09 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL HEAD STERILE PRODUCT |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDL |
| Date Received | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | 00801803602 |
| Lot Number | 63135590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-09 |