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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Information (3190)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00009.
 
Event Description
It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately nine years and five months post initial implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
It was reported the patient underwent left total hip arthroplasty.Subsequently a revision was performed approximately 11 years later due to pain, elevated metal ions, and corrosion.The femoral head was revised.No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D11: zimmer m/l taper femoral stem (00-7711-007-00, 60894782); zimmer versys femoral head -3.5 (00-8018-032-01, 60975943); zimmer tm modular acetabular shell (00-6202-054-22, 60961728); zimmer trilogy acetabular liner (00-6310-050-32, 60666550).
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined this is a duplicate of cmp-(b)(4).All information will be reported under cmp (b)(4).The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined this is a duplicate of cmp-(b)(4).All information will be reported under cmp (b)(4).The initial report was forwarded in error and should be voided.
 
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Brand Name
FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11171895
MDR Text Key226861512
Report Number0001822565-2021-00166
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K192660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00771100700
Device Lot Number60894782
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/28/2021
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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