MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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 knee arthroplasty on (b)(6) 2011.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2011.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Product has not been returned for evaluation.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified (1) similar complaints for item #159576 (including initiating complaint).There were (0) additional complaints against the lot #2115075.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can not be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.These part and lot combinations are not associated with any recalls as of current date.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 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: 12671286
• Report Number: 3002806535-2021-00458
• Device Sequence Number: 19886647
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: 05019279786220
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 159576
• Device Lot Number: 2115075
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male