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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 PROSTHESIS HIP

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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PROSTHESIS HIP Back to Search Results
Catalog Number 00771100900
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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 remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: item # 00620005622/ shell porous with cluster holes / lot # 61660755; part # unknown / unknown liner/ lot # unknown; part # unknown / unknown head/ lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00948, 0001822565 -2021 -00949, 0001822565 -2021 -00950.
 
Event Description
It was reported the patient was experiencing the following allegations post revision procedure: significant pain and discomfort; gait, impairment; poor balance; difficulty walking; component part loosening, impingement and/or detachment; metallosis; soft tissue damage; adverse local tissue reaction; dislocation; infection; and other injuries presently undiagnosed, which all require ongoing medical care. However, no further revision procedure has been reported to date. 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
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 Key11607911
MDR Text Key243560975
Report Number0001822565-2021-00951
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,distributor,health p
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number00771100900
Device Lot Number60921281
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 Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2008
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: 04/02/2021 Patient Sequence Number: 1
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