MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ C LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d-10: 161469 oxf twin-peg cmntd fem md pma lot# 65677676 159547 oxf anat brg lt md size 3 pma lot# 65860055 unknown cement, lot# unknown the device remains implanted and 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 a patient had an initial left unicompartmental knee arthroplasty a year ago.Subsequently, began to experience pain, joint effusion, instability, and buckling, received anti-inflammatory injection.A month ago, the patient had another follow-up appointment and was doing well and returned to all normal activities.All radiographic imaging shows implants in good position without complication.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 and/or corrected information.No product was returned, or pictures provided as the devices remain implanted; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The review identified that the patient had an initial left unicompartmental knee arthroplasty and subsequently began to experience pain, joint effusion, instability, and buckling.20ml of clear fluid was aspirated followed by a kenalog injection, the patient had another follow-up appointment and was doing well and returned to all normal activities.All radiographic imaging shows implants in good position without complication.Radiographs were provided and not sent to a radiologist because the findings are dictated within the medical records.And submission would not enhance the investigation.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 UNI TIB TRAY SZ C LM PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 19456783
• Report Number: 3002806535-2024-00201
• Device Sequence Number: 6735287
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)330201(10)65676714
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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 Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 65676714
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: SEEH11NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 73 KG