MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT X-SM SZ 6 PMA; KNEE PROSTHESIS

Catalog Number 159793

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported that one year post implantation, the patient came to the hospital for a checkup due to pain after an extreme knee flexion.It was then noticed that the bearing had dislodged from the joint system.The bearing was repositioned back into place, and the patient left after recovery from the procedure.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).D10 - associated products: oxford uni twin-peg femoral xs; item# 166940; lot# 6965547.Oxf uni tib tray sz b lm pma; item# 154720; lot# 6957462.G2 - foreign: china.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.Device is used for treatment.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 ANAT BRG LT X-SM SZ 6 PMA
• 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: 18084768
• MDR Text Key: 327538649
• Report Number: 3002806535-2023-00378
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279068968
• UDI-Public: (01)05019279068968(17)260128(10)6956221
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PO10014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 159793
• Device Lot Number: 6956221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female