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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ D STD 80MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. ARCOS CON SZ D STD 80MM; PROSTHESIS, HIP Back to Search Results
Catalog Number 11-301344
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Insufficient Information (4580)
Event Date 04/04/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).G2: new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the patient underwent a hip revision approximately twelve years post implantation due to loosening of the stem.The stem was removed and replaced.Attempts have been made and no further information is available.
 
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Brand Name
ARCOS CON SZ D STD 80MM
Type of Device
PROSTHESIS, 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 Key19203669
MDR Text Key341295330
Report Number0001825034-2024-01091
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2021
Device Catalogue Number11-301344
Device Lot Number188490
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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