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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Degraded (1153); Material Erosion (1214)
Patient Problems Failure of Implant (1924); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: us157852 m2a-magnum pf cup 739950, 13-103206 taperloc stem 882420, 139254 m2a-magnum tpr insrt 419680. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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: 0001825034-2022-00995.
 
Event Description
It was reported a patient underwent a right total hip arthroplasty performed. The patient was revised just over ten years post implant due to pain and elevated cobalt and chromium levels. It was discovered during the revision, pseudocapsules was noted, there was no obvious damage to tissues or surrounding structures; however, black discoloration associated with wear was noted. The femoral head was replaced with a dual mobility construct without complication. Attempts have been made and no further information has been provided.
 
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Brand NameM2A-MAGNUM MOD HD SZ 46MM
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 Key14239574
MDR Text Key290311212
Report Number0001825034-2022-00996
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
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number682120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2009
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: 04/28/2022 Patient Sequence Number: 1
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