MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
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.No associated products.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device has been retained by the surgeon.
Event or Problem Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2003.Subsequently, a revision procedure for the fractured oxford bearing due to wear was performed, on (b)(6) 2021.Patient involvement - revision.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: the event did not occur during surgery.Device revision or replacement the device is used for treatment.The reported event could not be confirmed as the product was not returned for review and information was insufficient to make a definitive confirmation.Visual inspection of the returned part could not be conducted as the product was not returned.The dimensional check was not carried out as the product was not returned for review.No assembly checks were carried out as the product was not returned for review.The material review was not conducted as the lot number stated on the per was not confirmed to correspond to the part number.Three attempts were made to request confirmation without success.Dhr review was not conducted as the lot number stated on the per was not confirmed to correspond to the part number.Three attempts were made to request confirmation without success.The product item no.159547 lot: s587066 has not been involved in any previous capas or field actions.No corrective actions are required at this time.Medical records and x-rays were requested but not provided.The risk assessment and occurrence rate could not be completed as an item number could not be confirmed.The root cause could not be defined with the available information if any additional information becomes available, then the complaint will be reopened and investigated further.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: a patient underwent an initial left knee arthroplasty on (b)(6), 2003.Subsequently, a revision procedure due to fractured oxford bearing due to wear was performed on (b)(6), 2021.Patient involvement - revision.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12959364
• Report Number: 3002806535-2021-00519
• Device Sequence Number: 1792871
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: 05019279785933
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 159547
• Device Lot Number: S587066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown