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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/27/2021
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 due to hospital policy.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 the patient is having a primary total hip replacement and a revision of an oxford unicompartmental knee replacement on the same side (right).The patient had issues of pain and inflammation on the right knee, hence he decided to have it revised at the same time as his hip.
Event or Problem Description
It was reported that the patient is having a primary total hip replacement and a revision of an oxford unicompartmental knee replacement on the same side (right).The patient had issues of pain and inflammation on the right knee, hence he decided to have it revised at the same time as his hip.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.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 is likely to be disease progression, which is not considered device related.No corrective action required at this time as the root cause of the reported event is not device related.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.H3 other text : hospital policy.

• Brand Name: OXF ANAT BRG RT 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: 12566960
• Report Number: 3002806535-2021-00435
• Device Sequence Number: 16419050
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• 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: 2015
• 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 Expiration Date: 09/24/2019
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 3427892
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 73 KG