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 2018-09-27 for BIOMET OFFSET TIBIAL TRAY 74MM N/A 141484 manufactured by Zimmer Biomet, Inc..
[122016120]
(b)(4) additional concomitant medical products: biomet offset tibial tray adaptor catalog #: 141491 lot #: 149400, biomet splined knee stem with screw 18mm x 80mm catalog #: 141618 lot #: 169810. The returned stem and offset adaptor were evaluated and the reported missassembly was confirmed, however, the seating issue was not verifiable as not all components were returned for evaluation. Visual inspection of the returned devices noted scratches and other markings consistent with being explanted and then removed from the tibial tray as reported. Dimensional analysis of the gap between the offset adaptor and the stem determined that the gap is larger than expected, indicating that the components may not have been fully mated during assembly. The device history records were reviewed and no discrepancies relevant to the reported event were identified. A definitive root cause could not be determined with the information provided. A summary of the investigation has been sent to the complainant. 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. Multiple mdr reports were filed for this event; please see all reports associated: 0001825034-2017-07109, 0001825034-2018-09206, 0001825034-2018-09209.
Patient Sequence No: 1, Text Type: N, H10
[122016121]
It was reported that the offset adapter, stem and tibial tray were noted to not be properly assembled during knee arthroplasty, resulting in difficulty seating the devices. The surgeon removed the screw 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 still would not fully seat, so the surgeon removed the polyethylene plug from the augment holes. The implants were then able to be seated successfully and the case was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09209 |
| MDR Report Key | 7915119 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-08-23 |
| Device Manufacturer Date | 2013-08-28 |
| Date Added to Maude | 2018-09-27 |
| 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 74MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2018-09-27 |
| Model Number | N/A |
| Catalog Number | 141484 |
| Lot Number | 212390 |
| Device Expiration Date | 2018-08-31 |
| 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 | 2018-09-27 |