MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-22 for BIOMET FND TIB TY POL COCR PC N/A 141356 manufactured by Zimmer Biomet, Inc..
[175910605]
(b)(4). Concomitant medical products: vanguard cr por fmrl-lt 65 catalog # 183068 lot # 187910, bmet regenx pri tib tray 67mm catalog # 141272 lot # 303980, modular splined stem 40mm catalog # 141369 lot # 473940, vngd ant stblzd brg 10x67 catalog # 189040 lot # 797610. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[175910606]
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to fractured patella prosthesis and clicking noise. The patella was removed and replaced. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00333 |
| MDR Report Key | 9617519 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2020-01-22 |
| 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 | BIOMET FND TIB TY POL COCR PC |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2020-01-22 |
| Returned To Mfg | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | 141356 |
| Lot Number | 868910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-22 |