MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; KNEE PROSTHESIS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Oxf uni tib tray sz b lm pma, item# 154720, lot# 6499378; oxf anat brg lt md size 5 pma, item# 159549, lot# 6376325.Foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00186.3002806535-2023-00187.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 knee revision surgery due to instability about three (3) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.A picture was provided of the explanted oxford femoral, tibial and bearing.It confirms that oxford components have been revised.There appears to be good coverage of bone cement however nothing further can be ascertained from the photograph.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.4 views of the left knee demonstrate a medial compartment hemi-arthroplasty with an oblique orientation of the femoral component.Suggestion of radiolucency along the femoral component.Lateral and patellofemoral compartment narrowing and osteophyte formation.Left knee medial compartment hemi arthroplasty with suggestion of loosening or malposition of the femoral component.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL MD
• Type of Device: KNEE PROSTHESIS
• 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: 17105856
• MDR Text Key: 316949666
• Report Number: 3002806535-2023-00188
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354854
• UDI-Public: (01)00887868354854(17)290530(10)J6561560
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 166942
• Device Lot Number: J6561560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 87 KG