MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR BIPOLAR CUP LINER ASSEMBLY; KWY

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the locking ring was outside of the liner upon opening.

Manufacturer Narrative

The bipolar liner was returned for evaluation.The locking ring was disassembled from the liner.Both parts show no signs of damage, and the ring was able to be assembled with the liner.Dimensional measurements were conforming to print specifications where measured.Device history record review identified no deviations or anomalies in the manufacturing process.The reported device is used for treatment.Review of the complaint history identified no previous complaints for the part lot combination.It is stated that the device was never implanted, and was found to be disassembled upon opening the box.The device functioned as normal upon return, and was conforming to specifications.With the information provided, a root cause for the reported disassembly cannot be determined with certainty.

• Brand Name: MULTIPOLAR BIPOLAR CUP LINER ASSEMBLY
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5678794
• MDR Text Key: 45913868
• Report Number: 0002648920-2016-00858
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00500104226
• Device Lot Number: 63134042
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1