MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 50X21X57 HUM HEAD; SHOULDER, PROSTHESIS

Catalog Number 113053

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: versa-dial/comp ti std taper cat: 118001 lot: 494610.Compr nano hmrl pps 40mm cat: 115740 lot: 499310.Lg hybrid glenoid base 4mm cat: 113956 lot: 889380.Pt hybrid glen post regenerex cat: pt-113950 lot: 280810.Foreign report source: (b)(6).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.Product remains implanted.

Event Description

It was reported that the patient experienced a rotator cuff tear and a revision procedure has been scheduled.

Event Description

It was reported that the patient has undergone a revision procedure due to tendon tear, limited range of motion and subluxation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right revision total shoulder, complex rotator cuff repair, supraspinatus and subscapularis, synovial biopsy shoulder.Deltoid was adhered to the underlying humerus.Subscapularis was completely detached as well as the anterior centimeter and a half or so of supraspinatus.2 stitches in subscap tendon.Synovial fluid sent for cultures, no evidence of frank infection.Humeral head was removed, morse taper plate was left.Glenoid was intact.Surgeon reported "some decent subscapularis tissue, although it was not spectacular".Multiple transosseous sutures through the lesser tuberosity as well as the anterior portion of the greater tuberosity using #2 hi-fi stitches.Subscap was reattached with mason-allen stitches tied medially.Device history record was reviewed and no discrepancies were found.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 50X21X57 HUM HEAD
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10267270
• MDR Text Key: 198695101
• Report Number: 0001825034-2020-02729
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113053
• Device Lot Number: 939540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 101