MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL LG; OXFORD CEMENTED FEMORALS

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: unilateral to total conversion.Patient involvement- revision surgery.
Additional Manufacturer Narrative
(b)(4).Initial report.The customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00093 and 3002806535-2021-00094.The investigation is in process.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 supplemental information.Complaint summary: the product was not returned or lot numbers were provided for review and evaluation.Dhr review could not be conducted as lot numbers were not provided and products were not returned to identify lots.The device is used for treatment.Products were deemed compatible.A review of the complaints database for 3 years before the notification date has identified the following information: there was only one (1) complaint about item #154602 (including the initiating complaint) due to revision for unknown reasons or others.There were five (5) complaints about item #159555 (including the initiating complaint) due to revision for unknown reasons or others.Medical records were not supplied for review.A definitive root cause could not be determined due to insufficient information provided or the product not being returned for review.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00093-1.3002806535-2022-00094-1.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: uni to total conversion.Patient involvement revision surgery.

• Brand Name: OXFORD UNI FEMORAL LG
• Common Device Name: OXFORD CEMENTED FEMORALS
• 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: 13692181
• Report Number: 3002806535-2022-00092
• Device Sequence Number: 1944804
• Product Code: NRA
• UDI-Device Identifier: 05019279388097
• UDI-Public: 05019279388097
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/21/2022

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: 154602
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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