MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; PROSTHESIS, KNEE

Catalog Number	159547
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Item#:161474 ;lot#:r2503466a ;item name: oxf twin peg cmntls fmrl md; multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00352.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent revision due to pain and instability.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified nicks, gouges and wear on the surface of the bearing component.The femoral component appears to have some scratches to the bearing surface and some bone ongrowth to the porous surface.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified aseptic loosening.Hemorrhage observed with what appeared to be some metallos in addition to a significant amount of scar on the anterior flange.When the knee was flexed to remove the bearing, the bearing was levered up and the femur "popped off.".No evidence of bony ingrowth on the back of the femur with posterior condyle showing no evidence of lytic areas and with bone intact without defects.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent revision due to pain, loosening, dislocation and metallosis.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Common Device Name: PROSTHESIS, KNEE
• 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: 17985180
• Report Number: 3002806535-2023-00353
• Device Sequence Number: 20879322
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)231017(10)371130
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/17/2023
• Device Catalogue Number: 159547
• Device Lot Number: 371130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 105 KG