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 2017-09-14 for BIOMET OFFSET TIBIAL TRAY ADAPTER N/A 141491 manufactured by Zimmer Biomet, Inc..
[86311212]
(b)(4). Udi: (b)(4). Concomitant medical product: biomet splined knee stem, cat#: 141618 lot#: 169810. Biomet offset tibial tray, cat#: 141484 lot#: 212390. Customer has 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. 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
[86311213]
It was reported that the offset adapter was not fully seated. It was noted that the implants were not assembled correctly. The screw was removed and the offset adapter was then disassembled from the tibial tray, at which time the offset adapter was found to be damaged. A replacement part was unavailable, so the surgeon re-trialed using a different size. The construct would not fully seat so the surgeon removed the polyethylene plug from the augment holes. The implants then seated and the case was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07109 |
| MDR Report Key | 6866733 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-09-14 |
| Date of Report | 2018-09-27 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2012-06-15 |
| Date Added to Maude | 2017-09-14 |
| 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 OFFSET TIBIAL TRAY ADAPTER |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-09-14 |
| Returned To Mfg | 2017-09-26 |
| Model Number | N/A |
| Catalog Number | 141491 |
| Lot Number | 149400 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| 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 | 2017-09-14 |