MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 5 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2022
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.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) 2020.Subsequently, a revision procedure due to instability was performed on unknown (b)(6) 2022.Original oxford (b)(6) 2020, is well fixed, but patient has become unstable.Previous prostheses information attached to this booking.Medium right 5 bearing removed.Medium right 7 bearing inserted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation, therefore the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.The device is used for treatment.X-rays or medical notes have not been provided.A dhr review identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified no additional similar complaints about the reported item number, and no additional complaints for the same item and lot combination for 3 years prior to the notification date.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.Corrective action and/or preventative action: no corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: a patient underwent an initial knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to instability was performed on (b)(6) 2022.Medium right 5 bearing removed.Medium right 7 bearing inserted.Patient height and weight are not available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: the explanted item details have now been correctly confirmed as: description: oxf anat brg rt md size 5 pma item: 159577 lot: 6641092.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.Subsequently, a revision procedure due to instability was performed.Original oxford is well fixed, but patient has become unstable.Medium right 5 bearing removed.Medium right 7 bearing inserted.

• Brand Name: OXF ANAT BRG RT MD SIZE 5 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: 13421290
• Report Number: 3002806535-2022-00041
• Device Sequence Number: 4854085
• Product Code: NRA
• UDI-Device Identifier: 05019279786237
• UDI-Public: (01)05019279786237(17)240930(10)6641092
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 159577
• Device Lot Number: 6641092
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/07/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/04/2022; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2019
• 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: 54 YR
• Patient Sex: Male