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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM RIMLOC 28MM 10DEG SZ2; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS ARCOM RIMLOC 28MM 10DEG SZ2; 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.Quantity 2 of this item/lot.This report is number 2 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
Visual inspection of the two returned liners noted a fractured nub on one and a damaged nub on the other, this was likely caused when attempting to seat the liners.Review of manufacture history records found no deviation or anomaly, the products likely left biomet conforming to print.It is possible that the liners were not aligned correctly, however, a definitive root cause cannot be identified.
 
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Brand Name
ARCOM RIMLOC 28MM 10DEG SZ2
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 Key5813595
MDR Text Key50177491
Report Number0001825034-2016-02725
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 06/16/2016
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 Date09/30/2018
Device Model NumberN/A
Device Catalogue Number11-105212
Device Lot Number599450
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2016
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 Manufactured09/28/2013
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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