MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; OXFORD CEMENTED FEMORALS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Metal Related Pathology (4530)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: oxf anat brg lt lg size 4 pma; item# 159555; lot# 948510; oxf uni tib tray sz c lm pma; item# 154722; lot# 813810.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2022 - 00485; 3002806535 - 2022 - 00487.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent a partial knee arthroplasty and approximately 8 years later a revision surgery was performed due to metallosis.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: "significant findings include lateral subluxation of the left tibia with respect to the femur and disrupted alignment of the medial compartment, suspected to be related to displaced bearing component which would have resided in the medial compartment but appears displaced superiorly.".A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• 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: 15930625
• MDR Text Key: 304954836
• Report Number: 3002806535-2022-00486
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: (01)05019279438259(17)240311(10)816300
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2024
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 816300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention