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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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ZIMMER BIOMET, INC. TAPERLOC HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number N/A
Device Problem Failure to Disconnect (2541)
Patient Problem Hip Fracture (2349)
Event Date 10/07/2015
Event Type  Injury  
Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-00321.Reported event was confirmed by review of provided medical records.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Not returned to manufacturer.
 
Event Description
It was reported during a revision procedure the taper insert was cold welded to the stem.While attempting to remove the insert from the stem, the proximal femur fractured.Attempts to obtain additional information have been made; however, no more is available at this time.
 
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Brand Name
TAPERLOC HIP SYSTEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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 Key7293673
MDR Text Key100843612
Report Number0001825034-2018-00322
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK030055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/31/2016
Device Model NumberN/A
Device Catalogue Number103204
Device Lot Number618010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2006
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 Sequence Number1
Treatment
139254 M2A-MAGNUM 42-50MM TPR INSRT-3 LOT 288770; 157450 HEAD, LOT 990380; US157856 CUP, LOT 117210
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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