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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 CEMENTLESS SIZE 9 STANDARD OFFSET PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 9 STANDARD OFFSET PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Necrosis (1971); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 - 00230.
 
Event Description
It was reported that the patient underwent a left hip arthroplasty. Subsequently, the patient was revised approximately 4 years later. The doctor said he recalled unexplained pain so he did a blood test which resulted in 'negative ion test' so resulted in a head revision where they swapped out to a biolox option head. Fluid was murky appearing and trunion did have signs of metallosis but not affected enough to revise stem. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameFEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 9 STANDARD OFFSET
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 Key12383426
MDR Text Key268648537
Report Number0001822565-2021-02390
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,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number65771100900
Device Lot Number62509324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
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