MAUDE Adverse Event Report: ZIMMER INC ZIMMER TM HUMERAL STEM; HSD

Catalog Number 00434811313

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that after reaming for a 13mm humeral stem, the stem fit loosely and was unstable upon insertion.A 14mm stem was inserted instead and fit correctly.

Manufacturer Narrative

Visual inspection of the tm humeral stem concluded that the device was returned in excellent condition and was found to be conforming to size specifications.Review of the device history records indicated the device was manufactured to specifications with no deviations to the standard manufacturing process.Inspection documentation shows all devices in its lot that were accepted/completed and sent to inventory met specifications.This device was used for treatment.Depending on bone quality and anatomy, the amount of press fit may be less than desired in some situations.It was determined that risks associated with humeral stems fitting loose are significantly lower than when stems fit tight.There are no previous complaints for this part/lot combination.With the supplied information an exact cause could not be determined at this time.

• Brand Name: ZIMMER TM HUMERAL STEM
• Type of Device: HSD
• 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: 5364575
• MDR Text Key: 36219705
• Report Number: 1822565-2016-00074
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434811313
• Device Lot Number: 63020503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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 Age: 51 YR
• Patient Weight: 68