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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: revision of oxford that was performed (b)(6) 2021.The reason was tibial loosening.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: oxf twin-peg cmntd fem sm pma.Catalogue number: 161468.Lot number: 064390.Medical product: oxf anat brg lt sm size 3 pma.Catalogue number: 159540.Lot number: 320420.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: oxf twin-peg cmntd fem sm pma.Catalogue number: 161468.Lot number: 064390.Medical product: oxf anat brg lt sm size 3 pma.Catalogue number: 159540.Lot number: 320420.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: revision of oxford that was performed (b)(6) 2021.The reason was tibial loosening.Patient outcome: revision.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to tibial loosening was performed on (b)(6) 2022.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay corrective and additional information.The implant and explant dates have been corrected.Patient information has been updated to the report.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.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.Review of complaint history identified 4 additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the implant is not within the scope or subject of any capa's field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.H3 other text : item not returned.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2021.Subsequently, a revision procedure due to tibial loosening was performed on (b)(6), 2022.

• Brand Name: OXF UNI TIB TRAY SZ C LM 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: 13618287
• Report Number: 3002806535-2022-00087
• Device Sequence Number: 20215463
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: 05019279388882
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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 Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 107270
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 04/05/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/25/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2020
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 82 KG