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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MMX48MM CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A 38MMX48MM CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number:11-173663 lot number: 821930 brand name: m2a 38mm mod hd, catalog number: rd118848 lot number: 413300 brand name: m2a 38mmx48mm cup, catalog number162502: lot number: 319330 brand name: answer 11x135 cocr lat. Multiple reports were submitted along with this report 0001825034-2022-00682. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient was revised due to elevated metal ions approximately 15 years post implantation. During the revision brownish fluid encountered with brownish lytic synovium, lysis in the greater trochanter, and bone graft with allograft chips placed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A 38MMX48MM CUP
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 Key13977446
MDR Text Key289007302
Report Number0001825034-2022-00683
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2022
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 Expiration Date12/31/2013
Device Model NumberN/A
Device Catalogue NumberRD118848
Device Lot Number413300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2003
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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