MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-12-10 for ALPHA INSERT ME WITH RIM II/32 N/A 01.00010.909 manufactured by Zimmer Gmbh.
[129780908]
Concomitant medical products - therapy date: (b)(6) 2015. The manufacturer received documents for review. The manufacturer did not receive the device for investigation. /where lot numbers were received for the explanted devices, the device history records were reviewed and found to be conforming. 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
[129780929]
Patient was implanted on the unknown side and underwent revision surgery due to metallosis, elevated metal ion levels and infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-01193 |
| MDR Report Key | 8146615 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2015-02-16 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2006-02-10 |
| Date Added to Maude | 2018-12-10 |
| 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 | ALPHA INSERT ME WITH RIM II/32 |
| Generic Name | ALPHA INSERT |
| Product Code | KWB |
| Date Received | 2018-12-10 |
| Model Number | N/A |
| Catalog Number | 01.00010.909 |
| Lot Number | 2314076 |
| Device Expiration Date | 2011-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-10 |