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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS HIP

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ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS HIP Back to Search Results
Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Naturally Worn (2988)
Patient Problems Ossification (1428); Erosion (1750); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Metal Related Pathology (4530); Insufficient Information (4580)
Event Date 07/06/2021
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 remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted concomitant products: part # unknown / unknown shell/ lot # unknown. Part #unknown / unknown stem/ lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01012. 0001825034 -2021 -01013.
 
Event Description
It was reported that patient underwent initial left total hip arthroplasty approximately 16 years ago. Subsequently, the patient has reported mild unknown symptoms and elevated chromium levels. However, no revision procedure has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN HEAD
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 Key11636255
MDR Text Key244491539
Report Number0001825034-2021-01011
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Yes
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: 04/08/2021 Patient Sequence Number: 1
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