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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 Problems Corroded (1131); Material Erosion (1214)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 08/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number: 11-173661 lot number:036230 brand name: m2a 38mm mod hd, catalog number:rd118848 lot number:942430 brand name: m2a 38mmx48mm cup,and catalog number:162501 lot number:170890 brand name: answer 9x125 cocr lat. Multiple reports were submitted along with this report: 0001825034-2022-00679. 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 with suspicion of adverse local tissue reaction approximately 15 years post implantation. During the revision there was a pseudo capsule, corrosion, lytic inflammation, gray staining, black lytic membrane material found and bone defect. 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 Key13928496
MDR Text Key288027273
Report Number0001825034-2022-00678
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 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2014
Device Model NumberN/A
Device Catalogue NumberRD118848
Device Lot Number942430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2004
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: 03/28/2022 Patient Sequence Number: 1
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