MAUDE Adverse Event Report: ZIMMER INC PERSONA ARTICULAR SURFACE PROVISIONAL SHIM; JWH

Catalog Number 42527900302

Device Problems Material Discolored (1170); Component Missing (2306); Material Deformation (2976); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device was missing a ball bearing after cleaning.

Manufacturer Narrative

Persona tibial articular surface provisional (ps tasp) shim was received for exam.Visual inspection of the returned ps tasp shim, 12mm, cd identified that only one ball bearing and associated spring were found missing.The ball bearing and spring were not returned for review.Visual inspection also reveals scuff marks on both the proximal and distal surfaces.The swage widths were found to be variable and minimal in some sections.Slight evidence of deformation of the swage in the distal/proximal direction was present.Scuff marks and discoloration were identified on the distal surface and also scuff marks on the proximal surface.Dimensions were found conforming to print specifications where measured.This is a known reported issue has been investigated through corrective actions.This device is used for treatment.A product history search revealed no additional complaints against the related product part and lot combination.It was reported that the ball bearing was found to be missing after cleaning.Corrective actions found that sonic cleaning may be a contributing factor to the ejecting of the ball and spring from the persona tasp shims, and that a user need of the device to be able to withstand ultrasonic cleaning was not identified during development.Zimmer initiated a field action on december 11, 2014.It was noted the field notification contains all tasp shim lots.A design change was made per material change to change the ball height note to require a maximum height.This lot was manufactured prior to the design change; therefore, the root cause is due to a previously addressed design issue.

• Brand Name: PERSONA ARTICULAR SURFACE PROVISIONAL SHIM
• Type of Device: JWH
• 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: 5510490
• MDR Text Key: 40856175
• Report Number: 1822565-2016-00725
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42527900302
• Device Lot Number: 62298361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1