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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 -6MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 -6MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Fracture (1260)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 11/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: cat#103202 taperloc por fmrl 7.5x135 lot#521400.Cat#105423 rnglc locking ring sz 23 lot#unk.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2021-01615, 0001825034-2021-01617.
 
Event Description
It was reported that the patient underwent a left hip arthroplasty approximately 6.5 years ago.Subsequently, patient was revised due to dislocation approximately 1.5 months later.The patient was revised again approximately 2 months later due to dislocation and it was found that the liner had fractured.Subsequently, approximately 4 years later, the patient was revised again.The acetabular cup, liner and head had broken resulting in pseudotumor formation and metallosis.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The event is related to the liner fracturing first, the harm of metallosis is secondary to the first event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The event is related to the liner fracturing first, the harm of metallosis is secondary to the first event.The initial report was forwarded in error and should be voided.
 
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Brand Name
FREEDOM CONSTR HD 36MM T1 -6MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11885374
MDR Text Key252677518
Report Number0001825034-2021-01616
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
PMA/PMN Number
K030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number11-107016
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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