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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Reaction (2414); Osteopenia/ Osteoporosis (2651)
Event Date 11/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: zimmer femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 4 extended offset reduced neck length, cat#: 65771100440, lot#: 62289137; zimmer femoral head sterile product do not resterilize 12/14 taper, cat#: 00801803603, lot#: 62346611; zimmer shell porous with cluster holes 50 mm, cat#: 00620205022, lot#62522176; zimmer liner standard 3. 5 mm offset 36 mm i. D. For use with 50/52/54 mm o. D. Shells, cat#: 00630505036, lot#: 62452970; zimmer bone scr 6. 5x35 self-tap, cat#: 00625006535, lot#: 62417713. 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 - 2020 - 00360.
 
Event Description
It was reported the patient underwent left hip revision approximately 5 years post initial implantation due to elevated cobalt levels. It was noted the cocr head was removed and replaced with a biolox head. 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 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 Key10351979
MDR Text Key201608826
Report Number0001822565-2020-02733
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
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number65771100440
Device Lot Number62289137
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 Received08/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2013
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: 07/31/2020 Patient Sequence Number: 1
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