MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 3 PMA; KNEE PROSTHESIS

Catalog Number	159575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); High White Blood Cell Count (4594)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxford ph3 cementless fem sz m; item# 154926; lot# 7442863.Oxf uni cmntls tib sz d rm; item# 166577; lot# 7419786.G2 - foreign: new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient experienced a fall due to unknown reasons a week post initial oxford partial knee surgery.The implants cannot be ruled out as causing/contributing to the fall with the limited information provided.Subsequently, the patient developed an infection 2 weeks post initial operation.Approximately 4 weeks after the initial operation, the surgeon reopened the knee to wash it out and changed the bearing to a larger size because they believe that due to the fall, the ligaments were stretched, therefore a larger size bearing was inserted to ensure correct knee balance.Only the bearing was exchanged the femur and tibial implants were kept insitu.It was also noted that the patient was non-compliant with surgeons post op plan and changed his own dressing multiple times despite being told not to.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the sterilization certificate confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the bearing ref and no additional similar complaints for the lot regarding instability.Complaints are monitored per complaint trending process.Review of the complaint histories found no additional related complaints for the femoral and tibial components and the reported part and lot combinations regarding instability.Medical records were not provided, however, an health care professional has reviewed the case and states that conforming sterile certs can rule out the device as causing/contributing to infection; however, the cause of the fall remains unknown.The implants cannot be ruled out as causing/contributing to the fall with the limited information provided.The poly was upsized to balance the knee and provide additional stability.Although the fall and revision is concurrent with infection, it is a serious injury through fall assessment as a revision surgery occurred to correct a complication in which the device cannot be ruled out.Radiographs were provided and reviewed by a radiologist.The review identified a medial compartment hemiarthroplasty with radiolucent bearing possibly seen.No evidence for periprosthetic radiolucency on the single ap film has been noticed.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 3 PMA
• Common Device Name: KNEE PROSTHESIS
• 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: 19114596
• Report Number: 3002806535-2024-00143
• Device Sequence Number: 7102431
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: (01)05019279786213(17)281107(10)7658502
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/27/2024

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: Lay User/Patient
• Device Catalogue Number: 159575
• Device Lot Number: 7658502
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose