MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD +3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532)

Event Date 08/28/2019

Event Type  Injury  

Event Description

It was reported the patient underwent a left hip revision approximately 14 years post implantation due to sudden pain and inability to walk.X-ray showed the femoral head had separated from the trunnion.During revision, the femoral head was visualized and had disassociated, black-stained fluid and synovial tissue were present.Attritional problem with the trunnion was observed and the tip appeared to have been worn away.Final femoral head and stem components were placed without complication.No additional information.

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01049.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6:component code: mechanical (g04) - head.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: developed pain and inability to walk, x-ray showed left femoral head had separated from the trunnion.Black-stained fluid and synovial tissue present, erosion through the capsule out into the sub fascial tissue.Femoral head visualized and had disassociated.Trunnion was observed to be worn away on the tip with attritional problem which necessitated removal of the well-fixed mallory head femoral component.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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 38MM MOD HD +3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14277729
• MDR Text Key: 290686173
• Report Number: 0001825034-2022-01048
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-173663
• Device Lot Number: 309210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 132 KG