MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

Catalog Number 118001

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 4 mdrs filed for the same patient (reference 1825034-2016-04923 / 04924 / 04926).(b)(4).

Event Description

It is reported that the patient is experiencing increasing pain, instability, and popping sounds following right shoulder arthroplasty one year post-operatively.Impingement was also noted at 3 month follow-up post-operatively, but has since been reported to have resolved.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was not received for evaluation, however device history records were reviewed and no discrepancies were found.Reported event was unable to be confirmed due to limited information received from the customer.Investigation results concluded that the snapping/popping and increased pain that occurred one year post op is due to patient accident/injury.For all other complications, the root cause is unable to be determined.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

It was reported the patient underwent a right total shoulder arthroplasty.Subsequently, the patient experienced pain, instability, supraspinatus/greater tuberosity tenderness, and biceps tendon tenderness noted at six (6) week post-operative follow-up.Continued pain, instability, supraspinatus/greater tuberosity tenderness, acromioclavicular joint tenderness, and impingement were noted at three (3) month post-operative follow-up.Lastly, instability, acromioclavicular joint tenderness, biceps tendon tenderness, and increasing pain were noted approximately one (1) year post-operatively.The condition is noted to be tolerated at this time, with no revision indicated to date.

• Brand Name: COMPREHENSIVE SHOULDER STANDARD TAPER 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: 6136528
• MDR Text Key: 61162570
• Report Number: 0001825034-2016-04922
• 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
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 118001
• Device Lot Number: 957350
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 113