MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TAPER LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-04619.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.

Event Description

It was reported that the liner did not disengage/release during a procedure.As a result, the surgeon had remove both the shell and the liner with a screw.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h1, h2, h3, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of medical records.Review of the revision operative notes confirms that the patient underwent revision left due to due to elevated metal ions, osteolysis and altr.During the procedure it was difficult to disengage the metal on metal liner from the shell.Removed the socket complete with one 25mm screw.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 TAPER LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9178892
• MDR Text Key: 162009087
• Report Number: 0001825034-2019-04620
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2010
• Device Model Number: N/A
• Device Catalogue Number: 15-105000
• Device Lot Number: 894270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SHELL, PN 15-103650, LN 588640; SHELL, PN 15-103650, LN 588640
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR