MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tingling (2171); Numbness (2415)

Event Date 08/01/2016

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 or deviation.In the instructions for use included with the device, it states under possible adverse effects: "intraoperative and early postoperative complications can include:.(2) temporary or permanent nerve damage resulting in pain or numbness to the affected limb." (b)(4).This is 2 of 5 reports submitted for the same patient (reference 1825034-2017-00272 - 00276).

Event Description

It is reported that patient experienced numbness and tingling in right finger tips less than 1 month post-operatively and mild pain and tenderness at 6 weeks post-op.The event resolved itself in 3 months without intervention.Surgeon alleges no deficiency in the product but indicates event may be related to procedure.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6277127
• MDR Text Key: 65727564
• Report Number: 0001825034-2017-00273
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 395910
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 60 YR
• Patient Weight: 89