MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER BIGLIANI/FLATOW HUMERAL STEM; SHOULDER PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that radiographic eval revealed the pt's humeral component had lucent lines of 2mm or more in zones 1, 2, 5 and 6.

Manufacturer Narrative

Info was received via published literature.Eval summary: surgical notes were not provided.X-rays were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Attempts have been made to obtain add'l info, however, no info has been received to date.With the supplied info an exact cause cannot be determined at this time.It is not suspected that the product failed to meet specifications.Review of the device history records was not possible as the product and/or lot numbers were unavailable.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available info, the need for corrective action is not indicated.Should add'l substantive info be received, the complaint will be reopened.Zimmer, inc., considers the investigation closed.

• Brand Name: UNK ZIMMER BIGLIANI/FLATOW HUMERAL STEM
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4240334
• MDR Text Key: 21448088
• Report Number: 1822565-2014-01488
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/30/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other