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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.(b)(6).

Event Description

Information was received based on review of a journal article titled, ¿short-term outcomes with a second-generation uncemented stem in total hip arthroplasty,¿ which retrospectively reviewed short term outcomes of bi-metric, 1497, and echo bi-metric, 1446, hip stems implanted between 1986 and 2014.All hips had a 100% survival rate after five years based on the study criteria and the authors noted that a posterior approach and larger head evidenced fewer cases of dislocation.Two patients were identified in the article that underwent total hip arthroplasties on unknown dates utilizing bi-metric stems.Subsequently, the patients experienced deep venous thrombosis.There has been no further information provided and the patient outcomes are unknown.

• Brand Name: UNKNOWN BI-METRIC
• 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: 5939678
• MDR Text Key: 54336600
• Report Number: 0001825034-2016-03517
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2016

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: 08/11/2016
• Initial Date FDA Received: 09/09/2016
• 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): Other