MAUDE Adverse Event Report: ZIMMER MULTIPOLAR CUP SHELL; KWY

Catalog Number 00500104500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 02/25/2014

Event Type  malfunction  

Manufacturer Narrative

Information was received from a surgeon who is not required to complete form 3500a.The device was not returned for inspection since it was implanted in the patient.Photographs were not received; therefore, the condition of the component is unknown.The device was reported to be a 45mm od bipolar metal shell which was verified to be from a lot manufactured on (b)(6) 2012 and packaged in a polyethylene bag.The device is used for treatment.This issue has been investigated and addressed through internal corrective and preventive actions.The reported lot number was confirmed to be manufactured prior to corrective and preventative actions taken on (b)(6) 2012.Field action z-0845-2016 was initiated on (b)(6) 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.Device not returned.

Event Description

During surgery, the implant was opened and was noted to have plastic remaining on the cup surface from the outer polyethylene bag.After a surgical team member removed the piece of plastic from the cup, the implant was used for the patient to complete the procedure.

• Brand Name: MULTIPOLAR CUP SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER; turpeaux industrial park; rt. #1, km 123.4, bldg. #1; mercedita,
• Manufacturer (Section G): ZIMMER PONCE; turpeaux industrial park; rt. #1, km 123.4, bldg. #1; mercedita, 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5571548
• MDR Text Key: 42503877
• Report Number: 2648920-2016-00120
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/26/2014

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: 05/31/2022
• Device Catalogue Number: 00500104500
• Device Lot Number: 62082189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2012
• 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