MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL XS; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Model Number N/A

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ oxf anat brg rt x-sm 3mm pma, item#: 160790, lot#: 3889046; oxf uni tib tray sz c rm pma, item#: 154723, lot#: 6181776.G2 ¿ foreign ¿ china.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 the patient underwent revision surgery approximately five years and four months after replacement of the right knee due to fracture of the femoral component prosthesis, pain and limited mobility.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided picture confirms a broken cemented femoral component.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 who reported that initial radiographs demonstrated relative posterior placement of the femoral implant of the unicompartmental knee arthroplasty with subsequent femoral implant fracture.The initial femoral implant malposition could conceivably contribute to the likelihood of an implant fracture due to abnormal stress upon the implant.With the available information, a definitive root cause cannot be determined however femoral implant malposition could conceivably contribute to the likelihood of an implant fracture due to abnormal stress upon the implant.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 XS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• 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: 17787369
• MDR Text Key: 323894486
• Report Number: 3002806535-2023-00310
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166940
• Device Lot Number: 3978954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• 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
• Patient Sex: Male
• Patient Weight: 84 KG