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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D-10: oxf twin-peg cmntd fem lg pma, item#, 161470 lot# 295290.Oxf anat brg lt lg size 4 pma, item# 159555, lot# 335430.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 that could be related to the reported event.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
It was reported that the patient underwent revision surgery due to loosening of unicompartmental components three and a half years post implantation.No further information has been provided.

• Brand Name: OXFORD UNI TIB TRAY SZ D 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: 19078047
• Report Number: 3002806535-2024-00137
• Device Sequence Number: 12368253
• Product Code: NRA
• UDI-Device Identifier: 05019279388905
• UDI-Public: (01)05019279388905(17)300214(10)912980
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 912980
• 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: 03/26/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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: Male