MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 4 PMA; PROSTHESIS, KNEE

Catalog Number 159548

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown oxford femur; unknown oxford tibia customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left hemi knee revision procedure approximately three years post implantation due to instability.The tibial bearing was replaced with a larger size.It was noted that the explanted bearing was full of penetrations.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product was returned and visually inspected which showed numerous indentations across both the superior and inferior articulating surfaces which is possibly due to wear.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of instability 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 LT MD SIZE 4 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6451203
• MDR Text Key: 71457682
• Report Number: 3002806535-2017-00181
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 159548
• Device Lot Number: 2894876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 80