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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROTHESIS, HIP
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ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROTHESIS, HIP Back to Search Results
Catalog Number 00801803202
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Date 03/28/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported a patient underwent a hip revision due to aseptic lymphocyte-dominant vasculitis-associated lesions.It was reported that no further information is available.
 
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Brand Name
FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
Type of Device
PROTHESIS, 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 Key19127871
MDR Text Key340414103
Report Number0001822565-2024-01293
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953337
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 04/17/2024
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 Health Professional
Device Expiration Date05/16/2022
Device Catalogue Number00801803202
Device Lot Number62076981
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/18/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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