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

Catalog Number 00500104700

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was implanted; therefore, the specific condition of the component is not able to be evaluated.This device is used for treatment.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action z-0845-2016 was initiated on january 11, 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported during surgery, it was discovered an implant was noted to have polyethylene packaging material adhered to cup surface of the component.The implant was cleaned off and used to complete the procedure.

• Brand Name: MULTIPOLAR BIPOLAR CUP SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER,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: 5572053
• MDR Text Key: 43018249
• Report Number: 2648920-2016-00159
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 00500104700
• Device Lot Number: 62114981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0845-2016
• Patient Sequence Number: 1