MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 5 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ medical devices: oxf twin-peg cmntd fem sm pma; item# 161468; lot# 264160.Oxf uni tib tray szalm; item# 154718; lot# 154718.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00303.3002806535 - 2023 - 00304.3002806535 - 2023 - 00305.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 initial that the patient underwent left unicompartmental knee arthroplasty.Approximately 2 years later, the patient reported pain, noise and instability with occasional sensation of giving away in the popliteal area and falls, no intervention provided, x-rays revealed the components to be in excellent position.A revision surgery was performed due to polyethylene dislocation and acl failure resulting in instability.During the revision noted acl deficit that caused the instability.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).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.Devices are used for treatment.Medical records were provided and reviewed by a health care professional/radiologist.The review identified the following: was getting in a recliner, felt a pop in her knee and her knee locked.X-ray: mobile bearing polyethylene component dislocated it flipped into the suprapatellar pouch.Failed left uka with dislocated polyethylene and acl failure resulting in instability spinal anesthesia.Previous incision utilized.Components removed with minimal bone loss.Acl was deficient and likely instability of the knee led to her polyethylene dislocation.No complications.Radiographs were provided and not reviewed as the medical records dictate the findings.With the available information, a definitive root cause could not 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: OXF ANAT BRG LT SM SIZE 5 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 17770952
• MDR Text Key: 323684373
• Report Number: 3002806535-2023-00303
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785889
• UDI-Public: (01)05019279785889(17)230504(10)865400
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 159542
• Device Lot Number: 865400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• 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 Sex: Female
• Patient Weight: 80 KG