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

Model Number	N/A
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
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 is contaminated.Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma, catalog no.: 161468, lot no.: unknown.Multiple mdr reports were filed for this event, associated reports: 3002806535-2021-00429.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that oxford mobile bearing implants were revised to a vanguard total knee.The tibial tray implant appeared to be loose when taking the parts out.Patient involved.
Additional Manufacturer Narrative
(b)(4).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, patient x-rays and a complaint history search.Review of the device history records could not be carried out as the lot.Numbers are unknown.Review of complaint history identified 2 similar complaints for the reported item 154718 and no additional complaints for the reported item 159540 (lot search not completed as lot numbers are unknown).These devices are used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.As the lot numbers are unknown it cannot not be confirmed that the implants have not been within the scope or subject of any field actions or recalls which could be attributed to reported event.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided, products have not been returned for evaluation.The root cause of the reported event cannot be determined with the information provided.The primary reason for the reported loosening of the tibial tray could not be determined without provision of immediate post-primary radiographs, additional patient information (such as activity level, bone quality), primary and revision surgery notes, and without examination of the revised components, however the presence of third body debris in the joint space and suboptimal position of the tibial tray may be contributing factors.Corrective or preventative action not required.The root cause of the reported event cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00429-1.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : device not returned due to contamination.
Event or Problem Description
It was reported that oxford mobile bearing implants were revised to a vanguard total knee.The tibial tray implant appeared to be loose when taking the parts out.Patient involved.

• Brand Name: OXF UNI TIB TRAY SZA LM
• 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: 12559744
• Report Number: 3002806535-2021-00428
• Device Sequence Number: 19170126
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: 05019279388844
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 154718
• Device Lot Number: UNKNOWN
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Female