MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; PROSTHESIS, KNEE

Catalog Number UNKNOWN

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.Concomitant medical products medical product: unknown oxford fem; catalog no.: unknown; lot no.: unknown.Medical product: unknown oxford tib; catalog no.: unknown; lot no.: unknown.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 the patient was scheduled for revision surgery due to pain and potential dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Visual examination of the provided pictures identified fracture at the base of the of bearing and what appears to be gouges or wear on the edges of the bearing surface.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Radiographs were provided.The review identified they were photocopies of the radiographs and were not sufficiently clear, therefore they were not sent for review by the radiologist.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

It was reported that the patient underwent a revision surgery due to inlay fracture and dislocation.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: PROSTHESIS, KNEE
• 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: 18225207
• MDR Text Key: 329196071
• Report Number: 3002806535-2023-00400
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male