MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Combined initial/final report customer has confirmed that the product will not be returned to zimmer biomet for investigation.Associated products: medical product: oxf anat brg rt md size 3 pma, catalog #: 159575, lot #:533620.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 781190.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, 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 8 complaints reported with the item 154723(including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product not returned.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure due to tibial sided failure was performed on (b)(6) 2021.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Common Device Name: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11930123
• Report Number: 3002806535-2021-00240
• Device Sequence Number: 4491197
• Product Code: NRA
• UDI-Device Identifier: 05019279388899
• UDI-Public: 05019279388899
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P01004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Expiration Date: 01/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 632830
• 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: 05/18/2021
• Initial Report FDA Received Date: 06/03/2021
• 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