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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported, that: unilateral to total conversion.Patient involvement- revision surgery.

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.

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 Description

It was reported, that: uni to total conversion.Patient involvement revision surgery.

• Brand Name: OXFORD UNI FEMORAL LG
• Type of Device: 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
• MDR Text Key: 286743983
• Report Number: 3002806535-2022-00092
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388097
• UDI-Public: 05019279388097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male