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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-UNK-M2A HEAD PROSTHESIS, HIP

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ZIMMER BIOMET, INC. HIP-UNK-M2A HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530)
Event Date 01/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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: 0001825034-2022-01541.
 
Event Description
It was reported the patient underwent a left hip revision approximately 14 years post implantation due to pain, squeaking, and elevated chromium/cobalt levels. Attempts have been made and no further information has been provided.
 
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Brand NameHIP-UNK-M2A HEAD
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14884539
MDR Text Key295119204
Report Number0001825034-2022-01540
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/25/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/01/2022
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 Received07/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2003
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: 07/01/2022 Patient Sequence Number: 1
Treatment
UNK CUP; UNK STEM
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