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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 17X150MM SPL TPR DIST PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS 17X150MM SPL TPR DIST PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Event Date 11/26/2018
Event Type  Injury  
Event Description
It was reported that during a revision procedure, the surgeon noted the right greater trochanter fracture was further fractured during the placement of the stem. The stem was removed and a longer stem was placed along with cables to reduce fracture site. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: ref 00-6250-065-25 lot 62869681 bone screw 6. 5x25 selftap; ref 00-8757-052-01 lot 62831028 continuum cluster-hole shell, 52; ref 98-0001-005-80 lot por st/tm cup/lg vit e. The device will not be returned for analysis, due to the device being discarded; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameARCOS 17X150MM SPL TPR DIST
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 Key13191453
MDR Text Key283400118
Report Number0001825034-2022-00064
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number11-300817
Device Lot Number538740
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/07/2022 Patient Sequence Number: 1
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