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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHETIC, HIP
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ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04174.
 
Event Description
It was reported that a patient underwent a left hip arthroplasty on an unknown date.Subsequently, the patient is being considered for revision due to metal on metal, elevated metal ions, and a pseudotumor.No revision has been reported to this date.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The device(s) involved in the event are competitor product.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The device(s) involved in the event are competitor product.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNKNOWN STEM
Type of Device
PROSTHETIC, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10894833
MDR Text Key217962999
Report Number0001825034-2020-04175
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/09/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN HEAD; UNKNOWN LINER
Patient Outcome(s) Hospitalization; Required Intervention;
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