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

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

The following report is being submitted to relay additional information received.Udi: (b)(4).Concomitant medical products: 115738 compr nano hmrl pps 38mm 696790; 113032 versa-dial 42x18x46 hum head 769260; 113954 md hybrid glenoid base 4mm 984350; pt-113950 pt hybrid glen post regenerex 066130.Report source- foreign- (b)(6).Investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00896; 0001825034 - 2019 - 00897; 0001825034 - 2019 - 00900.

Event Description

It was reported that the patient had initial shoulder arthroplasty, and subsequently experienced superficial surgical incision infection one month post implantation.The patient was prescribed antibiotics, and the dehiscence was noted to be improving within one month of treatment.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Dob - unknown month and day in (b)(6).Reported event was confirmed by review of follow up visit notes.As per first follow up notes, the patient presented today after having a wound discharge and dehiscence of the upper 1 cm of the scar, which developed 1 week back and patient does not show any signs of infection around the wound, no tenderness.On the second follow up the wound still has a bit of dehiscence proximally but no longer draining and appears much healthier.Dhr was reviewed and no discrepancies were found.Root cause was 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

No further event information available at the time of this report.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8395513
• MDR Text Key: 137992351
• Report Number: 0001825034-2019-00895
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060716
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 170590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 84