MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MOD ARTHRODESIS NAIL 5DEG COLLAR; ROD, FIXATION, INTRAMEDULLARY

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804); Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "metal sensitivity reactions," and, "discoloration from metallic components of the modular arthrodesis implant may be present in adjacent tissue or fluid." number 4 states, "loosening, migration and/or fracture of the implants can occur due to loss of fixation, trauma, misalignment, bone resorption, and/or excessive activity." product requested, not yet received.

Event Description

A patient who underwent a right knee arthrodesis procedure was revised 10 months later due to pain and instability.Noted during the procedure was metallosis in soft tissues, migration of the nail and fracture of the collar bolt medial screw.The arthrodesis nail was removed and replaced.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Deformation of the device was noted.A conclusive root cause of the event could not be determined.

Manufacturer Narrative

This follow-up report is being filed to correct information.

Manufacturer Narrative

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

Event Description

A patient who underwent a right knee arthrodesis procedure was revised 10 months later due to pain and instability.Noted during the procedure was metallosis in soft tissues, migration of the nail and fracture of the collar bolt medial screw.The locking collar assembly was removed and replaced.

• Brand Name: MOD ARTHRODESIS NAIL 5DEG COLLAR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 5675824
• MDR Text Key: 45780308
• Report Number: 0001825034-2016-01658
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK042409
• 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,Followup,Followup,Followup,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: CP260601
• Device Lot Number: 499460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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: 85