MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ AA LM PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combined initial/ final report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical devices: medical product: oxf anat brg lt sm size 4 pma, catalog #: 159541, lot #: 464930; medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 475920.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00429, 3002806535-2020-00430.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.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 159531, 1 similar complaint reported with the item 159541 and 2 similar complaints reported with the item 161468.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot numbers combination.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to lateral wear.A risk assessment has not been performed for the reported event as lateral wear (disease progression) is not device related.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product has not been returned.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.Subsequently, a revision procedure was performed on (b)(6) 2020 due to lateral wear.

• Brand Name: OXF UNI TIB TRAY SZ AA LM PMA
• Common Device Name: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10604742
• Report Number: 3002806535-2020-00428
• Device Sequence Number: 11745939
• Product Code: NRA
• UDI-Device Identifier: 05019279783137
• UDI-Public: 05019279783137
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159531
• Device Lot Number: 822520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention