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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Degraded (1153); Material Erosion (1214); Unintended Movement (3026)
Patient Problems Ossification (1428); Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Unspecified Tissue Injury (4559)
Event Date 02/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Item #: unknown cup lot #: unknown. Item #: unknown stem lot #: unknown. 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: 0001825034-2022-00357.
 
Event Description
It was reported that patient underwent an initial right total hip arthroplasty, subsequently was revised twelve years post initial implant due to pain. During the revision noted altr, impingement, limited mobility, ho and scar tissue. The head, neck and acetabulum were exchanged without difficulty. The stem remained implanted. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4). Concomitant products: item #: unknown cup lot #: unknown. Item #: unknown stem lot #: unknown. 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: 0001825034-2022-00357.
 
Event Description
It was reported that patient underwent an initial right total hip arthroplasty, subsequently was revised twelve years post initial implant due to pain. During the revision noted altr, impingement, limited mobility, ho and scar tissue. The head, neck and acetabulum were exchanged without difficulty. The stem remained implanted. Attempts have been made and no further information has been provided.
 
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Brand NameM2A-MAGNUM MOD HD SZ 52MM
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 Key13536319
MDR Text Key285634285
Report Number0001825034-2022-00358
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,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberN/A
Device Catalogue Number157452
Device Lot Number649260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2009
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: 02/15/2022 Patient Sequence Number: 1
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