MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIO-MODULAR SHOULDER; PROSTHESIS - SHOULDER

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Cisneros, l.G., atoun, e., abraham, r., tsvieli, o., bruguera, j., & levy, o.(2016).Revision shoulder arthroplasty: does the stem really matter? journal of shoulder and elbow surgery,25(5), 747-755.Doi:10.1016/j.Jse.2015.10.007.The product was not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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

Information was received based on review of a journal article titled, "revision shoulder arthroplasty: does the stem really matter?" a retrospective review was conducted of data that were prospectively collected on patients who underwent revision shoulder arthroplasty at our institute between 2005 and 2012.Three stemmed arthroplasty (sta) revisions rotator cuff failures with aseptic loosening were identified in the article.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN BIO-MODULAR SHOULDER
• 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: 6957333
• MDR Text Key: 89565259
• Report Number: 0001825034-2017-09008
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention