MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY STEM; PROSTHESIS, SHOULDER

Catalog Number 113611

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: versa-dial 54x21x64 hum head cat# 113063 lot# 763960.Versa-dial/comp ti std taper cat# 118001 lot# 957350.Pt hybrid glen post regenerex cat# pt-113950 lot# 376020.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent an initial left total shoulder arthroplasty (tsa).On follow up it was noted that there was a displaced fragment of the lesser tuberosity of the humerus.Approximately 5 months after the initial tsa, an open reduction internal fixation (orif) was performed to repair the fracture.Operative records indicate that the humeral head and glenoid components were stable.Further, a 1.0 mm titanium competitor needle cable was passed through the bone tunnels created.The needle cable was passed around the lesser tuberosity fragment in a cerclage fashion and then the cable was threaded.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, the stem was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the stem was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COMPREHENSIVE PRIMARY STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9732791
• MDR Text Key: 189190438
• Report Number: 0001825034-2020-00741
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113611
• Device Lot Number: 868740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 120