MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.The article was written j.R.Mclaughlin and k.R.Lee.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "long-term results of un-cemented total hip arthroplasty with the taperloc femoral component in patients with dorr type c proximal femoral morphology" attempts to investigate the longevity of un-cemented fixation of a femoral component in patients with dorr type c proximal femoral morphology.This study involved 350 hips in 320 patients over the course of four years; comparing 63 patients (68 hips) with dorr type c proximal femoral morphology with 257 patients (282 hips) with dorr types a and b morphology.All hips were implanted by a single surgeon and utilized a taperloc stem.One patient identified in the article underwent a total hip arthroplasty on an unknown date.Subsequently, the patient experienced a pulmonary emobolism which was successfully treated.There has been no further information provided.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: UNKNOWN HIP
• 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: 5847749
• MDR Text Key: 51187437
• Report Number: 0001825034-2016-02909
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

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 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: 07/06/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• 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): Required Intervention