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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
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00875101036-liner neutral 36 mm i. D. Size ii for use with 52 mm o. D. Size ii shell-62661367. 00875705202-shell with multi holes porous 52 mm o. D. Size ii for use with ii liners-61887857. 00489405820- trabecular metal⿢ acetabular revision system acetabular augment-62199762. 00877503602-biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14-2705086. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02269. 0001822565 - 2020 - 02270.

 
Event Description

It was reported the patient is experiencing femoral pain, stiffness of the hip joint, and occasional hip pain approximately five years post implantation. Surgeon indicated to the patient that the femoral pain was not due to the implant, that the implant appeared to be fine. 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 Key10205666
Report Number0001822565-2020-02271
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 06/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00771101320
Device LOT Number62258721
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 Received06/03/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/21/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient TREATMENT DATA
Date Received: 06/29/2020 Patient Sequence Number: 1
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