MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT X-SM SZ 3 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported a patient had an initial left unicompartmental knee arthroplasty.Subsequently, underwent a revision due to pain with noise and an avulsion fracture at the medial collateral ligament insertion that resulted in ligament laxity and dislocation of the bearing.The meniscus collateral ligament was repaired to the medial condyle and the bearing was revised without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4), d10 - medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford tibial component; item# unknown; lot# unknown.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

No further event information available at the time of this report.

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 that could be related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a medial compartment hemiarthroplasty with possible radiolucency along the femoral component on the two views of the left knee that were provided.Linear ossification along the medial aspect of the medial femoral condyle likely relates to patient's known mcl avulsion injury.Dislocated bearing within the suprapatellar bursa with associated metal on metal appearance within the medial compartment.Mild degenerative change of the lateral and patellofemoral compartments with moderate joint effusion.Medical records were provided and reviewed by a health care professional.The review identified an avulsion fracture of medial collateral ligament stop, injury to medial collateral ligament.Analysis and description of the cause of the incident: the patient's left knee medial collateral ligament insertion point was considered to have an avulsion fracture, local ligament laxity, and the medial compartment space enlarged, resulting in the meniscus spacer falling off.With the available information, a definitive root cause could not be determined.It is possible that the avulsion fracture and dislocation of the bearing are connected, however the exact sequence of events, or causative relationship among these factors cannot be definitely 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 3 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: 18639022
• MDR Text Key: 334498076
• Report Number: 3002806535-2024-00038
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 159790
• Device Lot Number: 6837444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: 62 YR
• Patient Sex: Female