MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Structural Problem (2506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Concomitant medical devices: medical product: oxf anat brg rt md size 7 pma, catalog #: 159579, lot #: 6871328.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the oxford pkr tibia was revised for instability on (b)(6) 2021.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the oxford pkr tibia was revised for instability on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.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.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the severity score associated with this failure mode is 3 (necessitates minor medical intervention) with an occurrence score of 2 (between 1 in 10,000 and 1 in 100,000).The severity score is in line with the risk file.Occurrence assessment: date: (b)(6) 2018 to (b)(6) 2021 (most up to date sales data): (b)(4) items sold.Number of complaints identified: 2 (including the reported complaint, (b)(4)) occurrence ratio: 2: 15,680 = 1: 7,840 this gives an occurrence score of 3.As the hazard for the identified complaints has not been determined, it is not reasonable to assign both events to the same line in the risk file, therefore, the calculated occurrence rate and occurrence score can not be used for comparison with the risk file, and no issue with the occurrence rate/score has been identified.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.H3 other text : the product has been discarded.

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• Common Device Name: OXFORD CEMENTED TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11378451
• Report Number: 3002806535-2021-00061
• Device Sequence Number: 11708936
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: 05019279388912
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 10/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 3657477
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention