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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # unknown / unknown taper stem/ lot # unknown.
 
Event Description
It was reported patient underwent a right hip revision surgery approximately seven years post implantation due to unknown reasons.Head component was revised.Attempts have been made and additional information on the reported event is unavailable at this time.
 
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
UNKNOWN HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11095810
MDR Text Key224390115
Report Number0001822565-2020-04245
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/01/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/11/2021
Supplement Dates FDA Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
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