MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T LINER EXTRACTOR 41 TAPER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Joint Dislocation (2374); Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2015

Event Type  Injury  

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted the root cause of the event was most likely due to the instrument being used beyond its useful life.

Event Description

It was reported that the patient underwent a total hip arthroplasty on (b)(6) 2006.Subsequently a revision procedure occurred on (b)(6) 2015 due to dislocation.The modular head and liner were removed and replaced.During the procedure, the liner extractor fractured and it is unknown if any fractured fragments remain in the patient.A competitor tool was utilized to complete the procedure.

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.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments it states ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.Inspect the instrument case and instruments for damage upon receipt and after each use and cleaning.Incompletely cleaned instruments should be cleaned until visibly clean, repeating as necessary." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 1 of 3 mdr's filed for the same event (reference 0001825034-2015-02224/ 02226).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Instrument was returned and fracture confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required root cause 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: M2A-T LINER EXTRACTOR 41 TAPER
• Type of Device: EXTRACTOR
• 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: 4796571
• MDR Text Key: 15430353
• Report Number: 0001825034-2015-02224
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-103635
• Device Lot Number: 472580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR