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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MICROBALANCE FEMORAL STEM PROSTHESIS HIP

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ZIMMER BIOMET, INC. MICROBALANCE FEMORAL STEM PROSTHESIS HIP Back to Search Results
Device Problem Corroded (1131)
Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: item # 010000703/ m2a magnum cup 58 mm /lot # unknown; item# unknown / m2a magnum 52 mm modular head / lot # unknown; item # unknown / m2a magnum 52 taper adapter / lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00736, 0001825034 -2021 -00745, 0001825034 -2021 -02969.
 
Event Description
It was reported patient underwent left hip revision surgery approximately 12 years post implantation due to allegations of pain, elevated levels of cobalt and chromium, tissue deconstruction, bone deconstruction, and metal wear. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameMICROBALANCE FEMORAL STEM
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 Key12719093
MDR Text Key279012291
Report Number0001825034-2021-02968
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,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2021
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

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
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