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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 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/24/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog number:00801803603, lot number: 62514865, brand name: femoral head. Catalog number:00620005820, lot number:62542641, brand name: trilogy shell. Catalog number: 00630505836, lot number:62598727, brand name: acetabular liner. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00309. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device not returned for evaluation.

 
Event Description

It was reported that the patient was revised due to unknown reasons approximately 4 years post implantation. 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
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 Key10179672
Report Number0001822565-2020-02195
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00771101120
Device LOT Number62630086
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 Received05/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2014
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: 06/22/2020 Patient Sequence Number: 1
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