MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-28 for BIOMET ILOK PRI TIB TRAY 75MM 141214 manufactured by Zimmer Biomet, Inc..
[87652614]
(b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06762, 0001825034-2017-07525, 0001825034-2017-07531, 0001825034-2017-07540 concomitant medical products: biomet finned pri stem 40mm, catalog# 141314 lot# 202100; maxim por ana pri fml 65 lt, catalog # 140072, lot # 258670; biomet ilok pri tib tray 75mm, catalog # 141214, lot # 212710; biomet arcom ap pat w/wire 28mm, catalog # 11-150825, lot # 044870; max pri dcm tib brng14x71/75mm, catalog # 11-146154, lot # 353950. (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to being discarded. The investigation is in process. Reported event was confirmed by review of photos. Visual inspection of the photos confirms severe wear and fracture of the tibial and the bearing components. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[87652615]
It was reported that that approximately 10 years after the patient's knee procedure a revision occurred due to extreme tibial wear. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07525 |
| MDR Report Key | 6901210 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2004-06-07 |
| Date Added to Maude | 2017-09-28 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET ILOK PRI TIB TRAY 75MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-09-28 |
| Catalog Number | 141214 |
| Lot Number | 212710 |
| Device Expiration Date | 2014-06-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-09-28 |