MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/02/2016

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2016-04950 - 04953).

Event Description

Clinical patient has reported ongoing pain, some mobility issues, and soreness and numbness around the scapula 2 years post-implantation.Instability was also noted one year post-operatively, but has since been reported to have resolved.No revision has been reported to date.

Manufacturer Narrative

This follow up report is being filed to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Clinical patient has reported ongoing pain with some mobility issues beginning around 6 weeks post-operative continuing through 1 year post-implantation instability was also noted one year post-operatively, but has since been reported to have resolved.However, soreness and numbness around the scapula was reported at 2 years post-implantation.No revision has been reported to date.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
• 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: 6136957
• MDR Text Key: 61187240
• Report Number: 0001825034-2016-04951
• 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,Followup,Followup
• Report Date: 05/07/2017

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 Expiration Date: 01/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 838260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/25/2017; 05/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 95