MAUDE Adverse Event Report: BIOMET UK LTD. ANATOMIC MENISCAL BEARING LEFT MEDIAL MEDIUM SIZE 4MM THICK; PROSTHESIS, KNEE

Catalog Number 159548

Device Problems Inadequate Instructions for Healthcare Professional (1319); Off-Label Use (1494); Packaging Problem (3007); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown oxford femur; unknown oxford tibia.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial right partial knee arthroplasty a left tibial bearing was implanted as it was difficult to differentiate the sides from the label.The tibial bearing was removed and replaced the next day.No additional patient consequences were reported.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: ANATOMIC MENISCAL BEARING LEFT MEDIAL MEDIUM SIZE 4MM THICK
• 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: 6430142
• MDR Text Key: 70734889
• Report Number: 3002806535-2017-00172
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 159548
• Device Lot Number: 3887388
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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