MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for OXF UNI TIB TRAY SZ B LM PMA N/A 154720 manufactured by Biomet Uk Ltd..
[181929082]
(b)(4). This is a combined initial and final mdr report. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the surgeon did not approve for return. Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 631620, medical product: oxf anat brg lt sm size 4 pma, catalog #: 159541, lot #: 372510. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00097, 3002806535-2020- 00099. As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history. We have not been provided with x-rays or any supporting documentation which could provide additional information. A review of the manufacturing history records confirms no abnormalities or deviations reported. For the item 159541; 1 piece was scrapped with opn numbers as 0020. A review of the complaint database over the last 3 years has found 25 similar complaints for this item code 161468, 14 similar complaints for this item code 154720 and 6 similar complaint for this item code 159541. Trends could not be identified from the complaint history review because the reason for the revision is unknown. The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison. At this time, no risk assessment can be conducted since the harm or reason for revision has not been reported. 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
[181929083]
It was reported that the patient underwent an initial left knee arthroplasty. Subsequently, a revision due to unknown reasons was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2020-00098 |
| MDR Report Key | 9768517 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2018-08-09 |
| Date Added to Maude | 2020-02-28 |
| 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 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXF UNI TIB TRAY SZ B LM PMA |
| Generic Name | KNEE ARTHROPLASTY |
| Product Code | NRA |
| Date Received | 2020-02-28 |
| Model Number | N/A |
| Catalog Number | 154720 |
| Lot Number | 733880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-28 |