MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X21X50 HUM HEAD; SHOULDER, PROSTHESIS

Catalog Number 113044

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

Patient Problem Tissue Damage (2104)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comprehensive stem, pn: 113630, ln: unknown; comprehensive glenoid poly, pn: unknown, ln: unknown; comprehensive hybrid glenoid post, pn: pt-113950, ln: unknown; comprehensive versa-dial taper adapter, pn: 118001, ln: unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Product not returned.

Event Description

It was reported that the patient was revised due to a failure of the rotator cuff.No further information is available.

• Brand Name: VERSA-DIAL 46X21X50 HUM HEAD
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8995249
• MDR Text Key: 157520776
• Report Number: 0001825034-2019-04005
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2019

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: Health Professional
• Device Catalogue Number: 113044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention