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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK VERSYS HERITAGE STEM; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK VERSYS HERITAGE STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Insufficient Information (4580)
Event Date 03/13/2024
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision due to instability and suspected loosening of the stem.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.This complaint cannot be confirmed.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.
 
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Brand Name
UNK VERSYS HERITAGE STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key19019977
MDR Text Key339115816
Report Number0001822565-2024-01115
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/02/2024
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? Yes
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
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/02/2024
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
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
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