MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK MULTIPOLAR BIPOLAR CUP LINER ASSEMBLY; KWY

Catalog Number 00500104226

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that the implant's locking ring was disassembled from the acetabular liner at the time the implant package was opened.

Manufacturer Narrative

The bipolar liner was returned for review.Visual inspection showed that the polyethylene ring was assembled to the liner; however follow up communication revealed that the polyethylene ring was partially outside the liner and a photograph was returned that confirms this.Dimensions were found conforming to print specifications where measured.Review of the device history records did not find any deviations or anomalies.Product history search revealed no additional complaints against the related part and lot combination.During evaluation it was confirmed that the inner package has visual references to allow operators identify if polyethylene ring was disassembled from the liner before it is packed and also the inner cover will adjust and prevent the movement of the ring inside the inner package.It was concluded that there are necessary controls within the actual procedures that will prevent, capture and identify if the polyethylene ring is outside the liner.Therefore there is no evidence to conclude that the assignable cause for the reported issue be related to the manufacturing process.A definite root cause cannot be determined with the information provided.This device is used for treatment.

• Brand Name: MULTIPOLAR BIPOLAR CUP LINER ASSEMBLY
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5289673
• MDR Text Key: 33883087
• Report Number: 2648920-2015-00426
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 00500104226
• Device Lot Number: 62878751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• 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