MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMUR COMPONENT; KNEE ARTHROPLASTY

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.Associated products: medical product: unknown oxford bearing item: unknown lot: unknown.Medical product: unknown oxford tibial tray item: unknown lot: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location unknown.

Event Description

It was reported by the hospital that the patient underwent an oxford partial knee arthroplasty on an unknown date.Subsequently, patient was revised on (b)(6) 2021 due to a fractured implant.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided.Post-primary radiographs have not been provided which are required for detailed analysis.In addition, we have not been provided with supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device location unknown.

Event Description

It was reported by the hospital that the patient underwent an oxford partial knee arthroplasty on an unknown date.Subsequently, patient was revised on (b)(6) 2021 due to a fractured implant.

• Brand Name: UNKNOWN OXFORD FEMUR COMPONENT
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12133623
• MDR Text Key: 260443525
• Report Number: 3002806535-2021-00299
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD FEMUR COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention