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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GEARY RT HA TRIFLANGE SZ 24 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. GEARY RT HA TRIFLANGE SZ 24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown head ¿ unknown part and lot; unknown liner ¿ unknown part and lot; unknown stem - unknown part and lot. Therapy date: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted at this time. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported patient is scheduled for a revision surgery to replace the cup component for unknown reasons. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameGEARY RT HA TRIFLANGE SZ 24
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 Key8089639
Report Number0001825034-2018-10800
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberPM158054
Device LOT Number232750
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 Received06/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2016
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: 11/20/2018 Patient Sequence Number: 1
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