MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT X-SM 4MM PMA

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 04/12/2018

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

When approving the invoicing of an oxford uncemented loan kit, it was noticed that an incompatible bearing was implanted.

Event Description

Incompatible bearing was implanted.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 RT X-SM 4MM PMA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7518439
• MDR Text Key: 108405243
• Report Number: 3002806535-2018-00808
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: N/A
• Device Catalogue Number: 160791
• Device Lot Number: 6072884
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1