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

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product is not available for return.Without the opportunity to examine the complaint device, 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.Associated package insert 01-50-0945, there are warnings in the package insert, under possible adverse effects,number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." 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.

Event Description

Information was received based on review of a journal article entitled, "improvements in survival of the nottingham total shoulder prosthesis: a prospective comparative study¿.The article addresses that 13 patients required a revision due to aseptic glenoid component loosening.There has been no further information provided and the patients outcome is unknown.

• Brand Name: UNKNOWN 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: 6917038
• MDR Text Key: 88380401
• Report Number: 0001825034-2017-07999
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN SHOULDER
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2014
• 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