MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50 TPR INSRT STD; 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 products: catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 632810.Catalog#: 157446 m2a-magnum mod hd sz 46mm lot#: 275010.Catalog#: 11-103205 taperloc por lat fmrl 11x142 lot#: 502860.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, 0001825034-2021-02059, 0001825034-2021-02060.

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.

Manufacturer Narrative

Upon reassessment of the reported event, the taper and stem were determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the taper and stem were determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: M2A-MAGNUM 42-50 TPR INSRT STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12159974
• MDR Text Key: 261303642
• Report Number: 0001825034-2021-02062
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 468080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 11/01/2021
• 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