MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem No Information (3190)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient had a revision due to incorrect bearing implanted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Udi : (b)(4).The reported revision surgery was performed due to an improper selection of the implant components.It was indicated by the complainant that there was no issue with the product.A review of the manufacturing history records confirms no abnormalities or deviations reported.From the information provided by the hospital the root cause of the reported issue was use error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7465587
• MDR Text Key: 106700487
• Report Number: 3002806535-2018-00754
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 6193780
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• 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