MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RNGLC+ LTD HOLE FIN SHL SZ54; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 12/22/2014

Event Type  Injury  

Event Description

It was reported that during a total hip arthroplasty on (b)(6) 2014, the acetabulum was properly reamed and sized.A trial 54 cup was put in place.Then, the real 54 cup was opened and implanted.After reduction of the hip with the trial liner, trial head, and trial broach, a size 32/24 hi-wall liner was inserted but would not lock.The cup was evaluated for bone and soft tissue, in case they were in the way of the liner.The cup was also slightly moved by the surgeon with a tap on the edge.The trial liner was inserted again, but upon insertion, the ring was noticed to be bent.A new ring was opened and implanted.Then, the surgeon attempted to insert the real liner, but it would still not lock in properly.At this point, the cup was explanted and a new 54 cup was put in and a 36/24 hi-wall liner was opened and inserted on the first try.The procedure was then completed by implanting the stem and head and reducing the hip.There was a delay in the procedure of over 30 minutes.

Manufacturer Narrative

Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.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.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch:.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.Product return date is january 12, 2015.Evaluation of the returned device found that it was acceptable to print tolerances.The device left biomet control conforming to print specification.The root cause for why the parts would not assemble remains unknown.

• Brand Name: RNGLC+ LTD HOLE FIN SHL SZ54
• 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 Key: 4415941
• MDR Text Key: 17266734
• Report Number: 0001825034-2015-00198
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 16-104154
• Device Lot Number: 577000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR