MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN BIGLIANI/FLATOW SHOULDER COMPONENT; SHOULDER PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Information was received via published literature.Please reference the literature, "implant survivorship and clinical outcomes of the bigliani-flatow shoulder prosthesis at a mean of five years: a post-marketing surveillance study from three centres".No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.

Event Description

It is reported that twenty-four patients died following shoulder arthroplasty due to unknown reasons.

Manufacturer Narrative

This follow-up report is being filed to correct information.

• Brand Name: UNKNOWN BIGLIANI/FLATOW SHOULDER COMPONENT
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6175734
• MDR Text Key: 62421817
• Report Number: 0001822565-2016-04614
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death