MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD STD NK; PROSTHESIS HIP

Catalog Number 11-163688

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: item # 15-105044/ m2a tpr hi carbon lnr/ lot # 111150; item # 15-103684/ m2a-t univ 2-hole shl/ lot # 380410; item # 103533/ low profile screw / lot # 306820; item # 103530/ low profile screw / lot # 21.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00937, 0001825034 -2021 -00938.

Event Description

It was reported that a patient underwent right hip revision surgery 16 years post implantation for unknown reasons.The head, shell, and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified the returned shell has lip damage as does the liner.The head has scuffing on the outside radius and there was some black debris inside of the taper.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

Event Description

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

• Brand Name: 32MM M2A HI CARBON HD STD NK
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11595456
• MDR Text Key: 243538012
• Report Number: 0001825034-2021-00939
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2016
• Device Catalogue Number: 11-163688
• Device Lot Number: 985970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention