MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 6 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: saw blades stryker power systems; item# 11-4844; lot# 63009; oxf uni tib tray sz c rm pma; item# 154723; lot# 3819019; oxford uni twin-peg femoral md; item# 166942; lot# j3608906; oxford cless res 3pk stry 6; item# 506273; lot# p398138.G2 - report source foreign: australia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty and approximately 7 years later a revision surgery was performed due to bearing dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that an initial right unicompartmental knee arthroplasty was performed.Approximately 7 years later, the patient experienced instability, pain, clicking, and locking in the joint.The patient underwent a poly exchange due to dislocation.During the revision, mild wear was noted on the poly which was exchanged without complication.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.Visual examination of the provided pictures identified mild wear on tibial surface of the bearing.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/radiographs were provided and reviewed by a health care professional.Review of medical records did not identify any intraoperative complications.Revision operation report identified that the femoral and tibial components were stable and that revision was due to mild bearing instability.Clear synovial fluid was sent for pathology, exam under anesthesia identified the bearing was mobile with mild instability but not able to be subluxed.Mild wear on tibial surface of the bearing was noted.6mm bearing was replaced with 8mm bearing with no noted complications.Review of two radiographs of right knee demonstrated a medial compartment hemiarthroplasty with possible dislocation of the polyethylene liner.Osteophyte formation within the lateral compartment and patellofemoral compartment.No evidence of fracture, joint effusion or radiolucency.Sizing of the implant is appropriate.Evidence of vascular calcification and osteopenia is present.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 RT MD SIZE 6 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: 17254556
• MDR Text Key: 318363297
• Report Number: 3002806535-2023-00224
• Device Sequence Number: 1
• Product Code: NRA
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2017
• Device Model Number: N/A
• Device Catalogue Number: 159578
• Device Lot Number: 2847991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG