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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SUP LOC ARCOM LNR 28MM HWALL01; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS SUP LOC ARCOM LNR 28MM HWALL01; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component or Accessory Incompatibility (2897)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2016-01092 / 02725/ 02726).
 
Event Description
It was reported that during a hip revision procedure, three acetabular liners would not properly seat in the acetabular cup.A smaller liner was cemented into the cup to complete the procedure without delay.
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected information.
 
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Brand Name
SUP LOC ARCOM LNR 28MM HWALL01
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5813602
MDR Text Key50180062
Report Number0001825034-2016-02726
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK911718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number15-103571
Device Lot Number269440
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/16/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2016
Initial Date FDA Received07/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2014
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 Sequence Number1
Patient Age80 YR
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