MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ C LM; KNEE PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10- oxf anat brg lt sm size 3 pma, item # 159540, lot# 7280185.Oxf pks c/less fem cocr sz sml pc/ha # 154925, lot# 7268399.G2 ¿ foreign ¿ japan.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 an initial unicompartmental knee arthroplasty, and approximately 1.5 months later experienced pain.Diagnosis confirmed a medial tibia bone fracture.Revision surgery was performed.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

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical records were not provided.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.

• Brand Name: OXF UNI CMNTLS TIB SZ C LM
• 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: 17008754
• MDR Text Key: 315997688
• Report Number: 3002806535-2023-00129
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354731
• UDI-Public: (01)00887868354731(17)320210(10)7157811
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166574
• Device Lot Number: 7157811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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): Required Intervention; Hospitalization
• Patient Sex: Female