MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD FEMORAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported, that: there was an oxford warranty surgery due to a patient having pain.Patient outcome: revision.

Manufacturer Narrative

(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00081 and 3002806535-2022-00082.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).

Event Description

It was reported, that: there was an oxford warranty surgery due to a patient having pain.Patient outcome: revision.

• Brand Name: UNK OXFORD FEMORAL
• Type of Device: UNK OXFORD FEMORAL
• 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: 13583414
• MDR Text Key: 288597879
• Report Number: 3002806535-2022-00083
• Device Sequence Number: 1
• Product Code: HRY
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNK OXFORD FEMORAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female