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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER MMC CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ZIMMER MMC CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: cat# unk, zimmer metasul ldh lrg dia head, lot# unk. No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Medical records were not provided. Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the patient was implanted with a zimmer mmc. Subsequently, the patient was revised approximately 9 years later due to evidence of metallosis. The head, liner, shell, and 2 bone screws were removed and replaced. No further event information available at the time of this report.
 
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Brand NameZIMMER MMC 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 Key13248820
MDR Text Key283748515
Report Number0001822565-2022-00074
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2021
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: 01/13/2022 Patient Sequence Number: 1
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