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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. FEMORAL HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem No Information (3190)
Event Date 01/05/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001822565 - 2021 - 00241.
 
Event Description
It was reported a patient underwent a hip revision due to trunionosis and elevated chromium levels.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
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Brand Name
FEMORAL HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11242964
MDR Text Key229089252
Report Number0001822565-2021-00240
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2021
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
Device Catalogue Number00801803601
Device Lot Number63415130
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/05/2021
Initial Date FDA Received01/28/2021
Supplement Dates Manufacturer Received03/02/2021
04/28/2021
Supplement Dates FDA Received03/11/2021
05/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN CUP.; UNKNOWN LINER.; UNKNOWN STEM.; UNKNOWN CUP; UNKNOWN LINER; UNKNOWN STEM
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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