MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Local Reaction (2035); Metal Related Pathology (4530)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 632810; catalog#: 11-103205 taperloc por lat fmrl 11x142 lot#: 502860; catalog#: 139256 m2a-magnum 42-50 tpr insrt std lot#: 468080.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2021-02055, 0001825034-2021-02060, 0001825034-2021-02062.

Event Description

It was reported that the patient underwent a revision procedure approximately 13 years and 4 months post implantation due to metal-on-metal ion disease.During the revision black synovial fluid was found.The stem, taper, cup and head were replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

The event was confirmed with medical records provided: a review of the available records identified findings of the reported issues ebl 200 c, black synovial tissue fluid, which was sent for gram-stain, cell count, tb fungus, aerobic anaerobic culture sensitivity, and crystals.An aggressive synovectomy was performed due to lymphocytic disease.A review of the primary op records indicated no complications during the procedure.Device history record was reviewed and no discrepancies relevant to the reported event 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-MAGNUM MOD HD SZ 46MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12159977
• MDR Text Key: 261671732
• Report Number: 0001825034-2021-02059
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 275010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR