MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE POLY LINER 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 07/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional report submitted for this event: mfr# 0001825034-2018-00146.Additional concomitant medical products: trabecular metal reverse spacer 9mm, pn00-4349-039-09, ln62459922.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not retrieved following the revision procedure.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left shoulder arthroplasty.Subsequently.The patient was revised after 10 months due to instability.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2018-02007.

• Brand Name: TRABECULAR METAL REVERSE POLY LINER 36MM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7218936
• MDR Text Key: 98226413
• Report Number: 0001825034-2018-00147
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• 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: 04/04/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-4349-036-00
• Device Lot Number: 62368359
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 04/02/3018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• 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): Hospitalization; Required Intervention