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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. METASUL HD 28MM L 12/14; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. METASUL HD 28MM L 12/14; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Host-Tissue Reaction (1297)
Event Date 11/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices: 4340-28-061 1366865 metasul insert apr 61/28; unknown stem; unknown cup.Foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 04239.
 
Event Description
It was reported patient underwent initial hip arthroplasty.Subsequently; the patient was revised approximately 10 months post implantation due to a pseudotumor.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under the correct mfr number.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under the correct mfr number.
 
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Brand Name
METASUL HD 28MM L 12/14
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11087333
MDR Text Key224063965
Report Number0001822565-2020-04240
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K993569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/05/2021
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 Number19.28.07
Device Lot Number2016910
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
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