MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TAPER 37/28MM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Implanted date: (b)(6) 2001; (b)(6) 2016.Explanted date: the product was explanted on (b)(6) 2016 and reimplanted during the same procedure.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, ¿do not reuse implants¿ this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00377-1 / 00872).Remains implanted.

Event Description

It was reported that a patient underwent an initial right total hip arthroplasty on (b)(6) 2001.Subsequently, a revision procedure has been indicated due to the age of the implant; however, no revision procedure has been reported to date.Additional information received reported that patient underwent a revision procedure on (b)(6) 2016 due to the age of the implant and suspected loosening.During the procedure, the cup and head were removed and replaced.It was reported that the liner was removed during the revision, and then reimplanted with the new cup and head.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.

• Brand Name: M2A TAPER 37/28MM LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5503895
• MDR Text Key: 40421456
• Report Number: 0001825034-2016-00872
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK993438
• 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,Followup
• Report Date: 05/12/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2005
• Device Model Number: N/A
• Device Catalogue Number: 15-105000
• Device Lot Number: 964920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2000
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other