MAUDE Adverse Event Report: ZIMMER INC UNKNOWN TM REVERSE SHOULDER GLENOSPHERE; SHOULDER PROSTHESIS

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported a patient was implanted with a non-compatible combination of zimmer biomet trabecular metal reverse system and a competitor's components.

Manufacturer Narrative

Concomitant medical products: catalog#unk, unknown tm reverse shoulder base plate, lot #unk.Operative notes were requested however none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.Zimmer-(b)(4) has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product as indicated on the packaging insert.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer (b)(4) considers the investigation closed.

• Brand Name: UNKNOWN TM REVERSE SHOULDER GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5346630
• MDR Text Key: 35354331
• Report Number: 1822565-2016-00016
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• 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
• Patient Sequence Number: 1