MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR FMRL 12.5X145; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported patient underwent a total hip arthroplasty on (b)(6) 2014.During the procedure, it was noted the incorrect product was packaged as the femoral stem.A larger femoral stem was utilized to complete the procedure.An hour delay occurred.

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

Photographs were forwarded for evaluation as the product was discarded during the procedure.The photographs revealed that an the inner packaging in the femoral stem box contained an acetabular cup.The review of device history records for both femoral stem and acetabular cup show that the femoral was manufactured aug 8, 2010 and the cup was manufactured in january 22, 2010.Neither product had to be repacked or be relabeled.As these products were made seven months apart from each other and as no rework or reprint of labels occurred, these products could not have left biomet control mixed or non-conforming.Reviewed sales history for both lots and found that units from both lots were shipped to thailand.It is believed that the units were mixed following their receipt with the customer.Product inadvertently scrapped.

• Brand Name: TAPERLOC POR FMRL 12.5X145
• 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: 3900542
• MDR Text Key: 4540589
• Report Number: 0001825034-2014-05831
• 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
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 103206
• Device Lot Number: 988150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2010
• 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 Weight: 54