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

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Muscle Weakness (1967); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices ¿ biomet compr nano hmrl pps 40mm, item # us-115740, lot # 402850.Biomet versa-dial 46x18x53 hum head, catalog # lot # 765420.Biomet lg hybrid glenoid base 4mm, catalog # 113956, lot # 816600.Biomet pt hybrid glen post regenerex , catalog # pt-113950, lot # 558340.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.This report is number 1 of 4 mdrs filed for the same patient (reference 0001825034-2017-04125 / 04132 / 04133 / 04134).

Event Description

It was reported that the patient underwent an initial shoulder arthroplasty procedure.Subsequently, as reported at the (6) six week post operative follow-up, the patient experienced pain, impingement, and mild coracoid process tenderness.At the three (3) month post operative follow-up, the patient experienced incision tenderness, pain, and mild instability.At the one (1) year post operative follow-up, the patient experienced impingement, instability, and continued mild pain.At the two (2) year post operative follow-up, the patient experienced left sided muscle weakness and coracoid tenderness.The pain reportedly resolved, however the muscle weakness is still ongoing.Attempts have been made to obtain additional information and further information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
• Type of Device: PROSTHESIS, SHOULDER SEMI-CONSTRAINED
• 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: 6652875
• MDR Text Key: 77915111
• Report Number: 0001825034-2017-04125
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• 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: 482970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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: 66 YR
• Patient Weight: 78