MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for NEXGEN FEMORAL COMPONENT N/A manufactured by Zimmer Biomet, Inc..
[187369557]
Zimmer biomet complaint number: (b)(4). Implant date - approximately 20 years ago. Concomitant medical products: kne-nexgen-bearings-unk; p/n: unk, l/n: unk, kne-nexgen-femorals-unk; p/n: unk, l/n: unk, kne-nexgen-tibial trays-unk; p/n: unk, l/n: unk, kne-nexgen-patellas-unk; p/n: unk, l/n: unk. Customer has not indicated that the product is in process of being returned to zimmer biomet for investigation. 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 - 2020 - 01161, 0001822565 - 2020 - 01168, 0001822565 - 2020 - 01169. Product location is unknown.
Patient Sequence No: 1, Text Type: N, H10
[187369558]
It was reported that the patient underwent an initial knee arthroplasty on an unknown date. Subsequently, a revision has been planned for unknown reasons. However, no revision procedure has been reported to date. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01168 |
| MDR Report Key | 9906337 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-31 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN FEMORAL COMPONENT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |