MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 11/12/2020

Event Type  Injury  

Event Description

It was reported that patient underwent a left hip revision after an unknown amount of time post implantation due to metallosis.During the revision, corrosion was found on the taper of the femoral stem and was easily removed by the surgeon.A minimal amount of tissue with chronic synovitis was removed form the inferior aspect of the acetabulum.The femoral head was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Medical records were reviewed by an hcp and noted explant of the head, trunnionosis, metallosis, dark brown tissue, corrosion on taper, chronic synovitis, and black foreign body material.Visual examination of the provided pictures identified a taper adapter and mod head, the taper adapter has damage on the outside.Device history records were unable to be reviewed as the part and lot numbers were not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01519, 0001825034-2022-01521 and 0001825034-2022-01522.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6a: unknown date in (b)(6) 2007.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

It was reported that patient underwent a left hip revision approximately 13 years post implantation due to metallosis.During the revision, corrosion was found on the taper of the femoral stem and was easily removed by the surgeon.A minimal amount of tissue with chronic synovitis was removed from the inferior aspect of the acetabulum.The femoral head was removed and replaced.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.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Event is confirmed via medical records and provided photo.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 information at the time of this report.

• Brand Name: M2A-MAGNUM MOD HD SZ 52MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14871827
• MDR Text Key: 295022032
• Report Number: 0001825034-2022-01520
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• 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,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 157452
• Device Lot Number: 521130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male