MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00469, 3002806535-2021-00470.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015 at (b)(6) hospital.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021 by (b)(6) at (b)(6) hospital.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation, and x-rays or medical notes have not been provided.Therefore, 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.A review of the complaints database for 3 years prior to the notification date has found the following: 3 similar reported complaints for item 154723 (including initiating complaint).17 similar reported complaints for item 161469 (including initiating complaint).5 similar reported complaints for item 159576 (including initiating complaint).There were no additional complaints against any of the item and lot combinations.These devices are used for treatment.The implants used have been confirmed to be compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when they left zimmer biomet is conforming to specification.The root cause of the reported event cannot be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.These part and lot combinations are not associated with any recalls as of current date.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00469-1.3002806535-2021-00470-1.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 : device discarded.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015 at (b)(6) hospital.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021 by dr.(b)(6) hospital.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Common Device Name: OXFORD CEMENTED TIBIAL TRAYS
• 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: 12726648
• Report Number: 3002806535-2021-00468
• Device Sequence Number: 19968021
• Product Code: NRA
• UDI-Device Identifier: 05019279388899
• UDI-Public: 05019279388899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 01/12/2025
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 691600
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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: 73 YR
• Patient Sex: Male