MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Degraded (1153); Fracture (1260); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: germany.Oxf uni cmntls tib sz d rm item#166577 lot#6195770, oxford ph3 cementless fem sz m item#154926 lot#6459441.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 experienced painful knee twisting trauma which resulted in bearing dislocation.A revision surgery took place where only the bearing was replaced, approximately three years after initial implantation.The bearing was reported to be worn.Due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.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 experienced painful knee twisting trauma which caused severe pain and difficulty with movement.The person experienced bearing dislocation as a result of the event.A revision surgery took place where only the bearing was replaced, approximately three years after initial implantation.The bearing was reported to be fractured.Attempts have been made and no further information has been provided.

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.Visual examination of the returned product identified that the bearing exhibited multiple wear marks to the articulating surfaces with the bottom articulating surface being deformed upwards.Severe wear is evident with a fracture posteriorly.It appears that the material has worn though until it has fractured.The tantalum balls are visible through the thinned material.A review of the device manufacturing records confirmed no abnormalities or deviations.Radiographs were provided and reviewed by a radiologist who reported the following: initial severe medial compartment arthrosis with subsequent placement of a medial unicompartmental arthroplasty with anatomic alignment.Subsequent displacement of the bearing as noted.Implant fit and alignment are maintained.Bone quality is mildly osteopenic.Further failure analysis was undertaken on the returned bearing by the research and development dept who concluded that it is not possible to confirm the exact root cause of the excessive wear and fracture of the oxford bearing in this instance.However, soft tissue laxity, the patient¿s high body weight and occupation requiring a kneeling position may have resulted in the bearing overhanging and tracking against the posterior edge of the tibial tray.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 4 PMA
• Type of Device: UNICONDYLAR 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: 16032524
• MDR Text Key: 305974699
• Report Number: 3002806535-2022-00506
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2023
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 6429086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 194 KG