MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MLRY-HD LAT POR FMRL 13MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Failure to Disconnect (2541)

Patient Problem No Code Available (3191)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported patient underwent a total hip arthroplasty on (b)(6) 2011.Subsequently, patient was revised on (b)(6) 2014 due to unknown reasons.During the procedure, the taper adapter allegedly would not disengage from the femoral stem.An extended osteotomy trochanter procedure was performed to remove the taper adapter and femoral stem.A delay of over 30 minutes occurred during the procedure.

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.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.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the event could be due to maligment and suboptimal positions of the components, which may have contributed to fusing of the components.This information has already been relayed in the associated report reference 3002806535-2014-00165.

Manufacturer Narrative

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

Event Description

It was reported patient underwent a total hip arthroplasty on (b)(6) 2011.Subsequently, patient was revised on (b)(6) 2014 due to unknown reasons.During the procedure, the taper adapter allegedly would not disengage from the femoral stem.An extended osteotomy trochanter procedure was performed to remove the taper adapter and femoral stem.A delay of over 30 minutes occurred during the procedure.

• Brand Name: MLRY-HD LAT POR FMRL 13MM
• 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: 3903244
• MDR Text Key: 21803047
• Report Number: 0001825034-2014-05810
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-104213
• Device Lot Number: 856420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2009
• 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: 48 YR
• Patient Weight: 80