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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Information (3190)
Event Date 06/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device location remains unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02566.
 
Event Description
It was reported that patient underwent a revision 1 day post implantation due to the proximal body of the stem not seating properly.The stem was fully engaged.The active articulation head, modular head and taper adaptor were removed and replaced.No additional information available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
ARCOS 15X150MM SPL TPR DIST
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10219696
MDR Text Key197184391
Report Number0001825034-2020-02613
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number11-300815
Device Lot Number190620
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ARCOS CON STD CAT#11-301301 LOT#395850; CER BIOLOXD HD CAT#650-1055 LOT#2958701; G7 DUAL MOBILITY LINERCAT#110024462 LOT#703320; G7 OSSEOTI SHELL CAT#110010243 LOT#6627120; ARCOS CON STD CAT#11-301301 LOT#395850; CER BIOLOXD HD CAT#650-1055, LOT#2958701; G7 DUAL MOBILITY LINERCAT#110024462 LOT#703320; G7 OSSEOTI SHELL CAT#110010243 LOT#6627120
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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