MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM SMALL BEARING 3MM THICK LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products - oxford lm tibial tray catalog 159531 lot 377706; oxford twin peg femur catalog 161468 lot 3011960.

Event Description

It was reported that the patient underwent a left knee revision procedure approximately four years post implantation due to instability, the tibial bearing was removed and replaced.It was noted that the surgeon believed the patient had suffered a medial collateral ligament injury.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as there are no allegations of failure of the device.The initial report was forwarded in error and should be voided.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM SMALL BEARING 3MM THICK LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• 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: 6376820
• MDR Text Key: 69045602
• Report Number: 3002806535-2017-00108
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 3034001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR