MAUDE Adverse Event Report: ZIMMER INC ZIMMER SHOULDER CUSTOM AUGMENT; SHOULDER PROSTHESIS

Catalog Number 32855091032

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other device used: catalog #32855091031, zimmer shoulder custom augment, lot #95006410.Only this component was returned for evaluation on 09/30/2015.This report will be amended when our investigation is complete.

Event Description

It is reported that custom made augments were packaged incorrectly.A 15 degree large augment was ordered; however, a 30 degree large augment was in the box.When the 30 degree large augment box was opened, the 15 degree large augment fell out.

Manufacturer Narrative

As returned the augment block is in like new condition, and the returned packaging material indicates a 15 degree augment.The returned augment block measures as a 30 degree device.Review of the device history records did not find any deviations or anomalies.The device was used for treatment.The investigation identified the root cause as incorrectly retrieving the program for production of the custom implants.As these are custom devices, their programs were not stored in the same manner as standard production, controlled documents.The wrong program was run for the part number.Additionally the inspection plans for custom devices consists of a marked up drawing provided by custom development.In this case the inspection dimensions cited on the drawing did not differentiate between the 15 degree and 30 degree components.Therefore, the issue was identified in inspection.As an output of this investigation, custom device programs are now placed in the same controlled location as standard production programs, and updated prints with differentiated measurements were provided for inspection.This issue resulted in a field action in australia only to retrieve the affected lots.

• Brand Name: ZIMMER SHOULDER CUSTOM AUGMENT
• 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: 5123341
• MDR Text Key: 27588126
• Report Number: 1822565-2015-02066
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 32855091032
• Device Lot Number: 95006411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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: 76 YR