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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Patient Device Interaction Problem (4001)
Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Event Date 03/10/2020
Event Type  Injury  
Event Description
It was reported the patient underwent a right hip revision approximately 14 years post implantation due to pain and elevated metal ions. During the revision metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the trunnion and acetabular component with no bone growth on posterior surface, and breach to bone in the acetabulum. The head and cup were exchanged without complications. The stem remained implanted. No additional information.
 
Manufacturer Narrative
(b)(4). Concomitant products: cat#us157848 m2a-magnum pf cup 48odx42id; cat#157442 m2a-magnum mod hd sz 42mm; cat#11-103206 taperloc por lat fmrl 12. 5x145. 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 - 00786, 0001825034 - 2022 - 00787 , 0001825034 - 2022 - 00788.
 
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Brand NameM2A-MAGNUM 42-50MM TPR INSRT-6
Type of DevicePROSTHESIS, 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 Key13976239
MDR Text Key288370845
Report Number0001825034-2022-00789
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number139252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
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