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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHETIC, HIP
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ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 06/14/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01552; 0001825034-2023-01551; 0001825034-2023-01549.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint as no reason for revision, not product information, or medical records were provided.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Device location is unknown.
 
Event Description
It was reported that the patient underwent a revision procedure due to unknown reasons.Attempts have been made to obtain additional information and at this time there is no additional information available.
 
Event Description
Upon reassessment of the reported event and additional information received, it was determined that the event reported under mfr #0001825034-2023-01554 is not reportable.The initial report was forwarded in error as a revision procedure never occurred.
 
Manufacturer Narrative
Upon reassessment of the reported event and additional information received, it was determined that the event reported under mfr #0001825034-2023-01554 is not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNKNOWN LINER
Type of Device
PROSTHETIC, 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 Key17317580
MDR Text Key319022935
Report Number0001825034-2023-01554
Device Sequence Number1
Product Code PBI
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
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 Received07/14/2023
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 Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN HEAD, UNKNOWN STEM, UNKNOWN CUP
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
Patient SexFemale
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