MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP +6 41MM; EXTREMITY PROSTHESIS

Catalog Number 115326

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Product was not returned to zimmer biomet for investigation.The complaint description and investigation findings can only indicate that a poor fixation of the taper adapter to the baseplate occurred.Although the first taper dimension was found to be out of specification it can be attributed to the mechanical damaged present at the taper opening.The sales representative indicated that no trauma was identified by the patient during the second disassociation event.The ifu warns "disassociation's of modular components have been reported.Failure to properly align and completely seat the components together can lead to disassociation".The baseplate tapers are 100% checked during manufacturing and after porous coating.It is reasonable to state the components left biomet conforming the design specifications.Review of complaint history found no additional related issues for these items.Review of device history records found unrelated deviations during the manufacturing process.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.This report is being submitted late as it has been identified in remediation.

Event Description

Revision due to disassociated glenosphere.

• Brand Name: COMP RVRS SHLDR GLNSP +6 41MM
• Type of Device: EXTREMITY 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: 7114435
• MDR Text Key: 94790058
• Report Number: 0001825034-2017-11135
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 115326
• Device Lot Number: 496380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2010
• 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