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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X200MM PRX TPR DIST PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS 15X200MM PRX TPR DIST PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 06/14/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign: country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01574.
 
Event Description
It was reported the patient underwent a right hip revision approximately 8 weeks post implantation due to the arcos distal slotted stem subsiding. No additional information.
 
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Brand NameARCOS 15X200MM PRX TPR DIST
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14934085
MDR Text Key295352721
Report Number0001825034-2022-01573
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number11-300615
Device Lot Number363970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2017
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: 07/06/2022 Patient Sequence Number: 1
Treatment
CAT# 11-301342 LOT# 111130 ARCOS CONE
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