MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING; PROSTHESIS, KNEE

Catalog Number 159572

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: oxford pks cocr size a rm std catalog #: 154719 lot #: 3572181 and oxford pks cemented twin peg fem cocr sml catalog #: 166941 lot #: j3576516.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.

Event Description

It was reported the patient underwent a right partial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately six months post-implantation due to instability.Additional information on the reported event is unavailable.No additional patient consequences were reported.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING
• 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: 6532021
• MDR Text Key: 74008706
• Report Number: 3002806535-2017-00267
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 159572
• Device Lot Number: 3648431
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention