MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-30 for FEMORAL STEM 12/14 NECK TAPER PLASMA SIZE 11 STANDARD OFFSET N/A 00771101100 manufactured by Zimmer Biomet, Inc..
[186722205]
(b)(4). Concomitant medical products: 00625006530 bone scr lot 61911791, 00625006530 bone scr lot 61920608, 00801803603 femoral head lot 61907738, 00875101236 neutral liner 36 mm lot 61666132, 00875705602 shell with multi holes lot 61914238. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product remains implanted. The investigation is in process. 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: 0002648920 - 2020 - 00211 head.
Patient Sequence No: 1, Text Type: N, H10
[186722206]
Patient? S legal counsel reported patient underwent right total hip arthroplasty nine years ago. Patient claims to suffer unknown injuries and is considering revision surgery on an unknown date. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01117 |
| MDR Report Key | 9900826 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2011-12-11 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2011-11-18 |
| Date Added to Maude | 2020-03-30 |
| 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 | FEMORAL STEM 12/14 NECK TAPER PLASMA SIZE 11 STANDARD OFFSET |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LZO |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 00771101100 |
| Lot Number | 61915146 |
| 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 | 2020-03-30 |