MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN TAPERLOC FEMORAL STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.The following could not be completed with the limited information provided in the article: date of event - ni, expiration date - ni, date implanted - ni, date explanted - ni, initial reporter - this article was written by young-kyun lee, yong-chan ha, woo-lam jo, tae-young kim, woon-hwa jung, kyung-hoi koo, manufacture date ¿ ni.

Event Description

It was reported in a journal article, eight hip had developed grade i heterotopic ossification and two hips had developed grade ii heterotopic ossification at follow-up.The minimum follow-up period was 24 months.All of the acetabular cups and femoral stems had radiographic evidence of bone ingrowth at the time of last follow-up.

• Brand Name: UNKNOWN TAPERLOC FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6414258
• MDR Text Key: 70242708
• Report Number: 0001825034-2017-01672
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2017

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: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other