MAUDE Adverse Event Report: BIOMET TRAUMA VHS LAG SCR 12.7X105 W/COMP SC; APPLIANCE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Impaired Healing (2378)

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 that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "metal sensitivity, or allergic reaction to a foreign body." this report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-01611 / 01612).

Event Description

Patient reported experiencing pain, swelling, hot skin around the wound, and slow recovery approximately two months post-implantation.Patient suspects a nickel allergy.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

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).

Event Description

Patient reported experiencing pain, swelling, hot skin around the wound, and slow recovery approximately two months post-implantation.Patient suspects a nickel allergy.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Patient underwent allergy testing that stated that the patient does not have a nickel allergy.However, the patient walks with a limp using a cane to walk.

• Brand Name: VHS LAG SCR 12.7X105 W/COMP SC
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 5659052
• MDR Text Key: 45293536
• Report Number: 0001825034-2016-01612
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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: 200205
• Device Lot Number: 255720
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Age: 80 YR
• Patient Weight: 74