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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: there was a revision due to an unknown reason.Oxford warranty.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: the client has indicated that the product is in process of being returned to zimmer biomet for an investigation.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00204 and 3002806535-2022-00206.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records for part # 161469 and lot # 631020 were reviewed and researched for deviations and/ or anomalies with no deviations/ anomalies identified.No deviation history has been found.The device history records for part # 154726 and lot # 226730 were reviewed for deviations and/ or anomalies with the following deviations/anomalies identified: one-piece common cause scrap atop #0040 polish complete.The device history records for part # 159548 and lot # 482700 were reviewed and researched for deviations and/ or anomalies with no deviations/ anomalies identified.No deviation history has been found.The device is used for treatment.A review of reported parts confirms compatibility.A complaint history review for 161469 identified three (3) previous complaints.The complaint history review for 154726 did not identify any previous complaints.The complaint history review for 159548 did not identify any previous complaints.Medical records/radiographs were not provided.The likely condition of the device when it left zimmer biomet is conforming to the specification.The definitive root cause of the reported event cannot be determined with the information provided.No corrective actions or preventive actions are required at this time.Field action review.It has been confirmed that the implants (161469, 154726 & 159548) are not within the scope or subject of any field actions or recalls which could be attributed to the reported events.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00204-1, 3002806535-2022-00206-1.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: there was a revision due to unknown reasons.Oxford warranty.Patient outcome: revision.

• Brand Name: OXF UNI TIB TRAY SZ E LM PMA
• Common Device Name: OXFORD 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: 14039550
• Report Number: 3002806535-2022-00205
• Device Sequence Number: 14592345
• Product Code: NRA
• UDI-Device Identifier: 05019279388929
• UDI-Public: 05019279388929
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 05/24/2022

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 Expiration Date: 09/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 154726
• Device Lot Number: 226730
• Was Device Available for Evaluation?: Yes
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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: Required Intervention; Hospitalization
• Patient Sex: Male