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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 Problems Corroded (1131); Material Erosion (1214)
Patient Problems Ossification (1428); Necrosis (1971); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: m/l taper femoral stem (00-7711-010-00, 62059159). Versys femoral head +0 (00-8018-032-02, 62091865). Trilogy acetabular shell (65-6200-050-22, 62049516). Trilogy acetabular liner (00-6305-050-32, 60999098). Bone screw (00-6250-065-25, 62136805). The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00014, 0002648920-2021-00013.
 
Event Description
It was reported that patient underwent a right total hip arthroplasty. Subsequently, patient underwent a revision procedure approximately 7 years later due to elevated metal ion levels, pain, ho, tissue damage, synovitis/bursitis, implant wear, scar tissue, necrosis, and invivo corrosion. The head and liner were revised. No further event information available at the time of this report.
 
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Brand NameFEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11375671
MDR Text Key233441302
Report Number0001822565-2021-00507
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberN/A
Device Catalogue Number00771101000
Device Lot Number62059159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
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