MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT; HSX

Catalog Number 00584201602

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

Patient Problem No Information (3190)

Event Date 12/08/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the returned product confirmed the reported condition.Further investigation revealed that the femoral component was packaged with a raw material lot of polyethylene bags that were previously identified as having the potential to adhere to highly polished surfaces, which may leave a residue and in some cases a portion of polyethylene on the device.Evaluation of the polyethylene bags has been completed to assess risk to the patient and found "risk assessment indicates that the likelihood of a toxic effect from the low density polyethylene ldpe bags is negligible".Independent lab testing found the residue to be non-toxic.Testing has been that shows the residue can be removed with a cloth moistened with water or isopropyl alcohol.The lot was manufactured on may 25, 2012 which is prior to the capa implementation date of december 20, 2012.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 (b)(4) 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 is reported that the inner plastic packaging was stuck to the implant.There was a fifteen minute surgical delay.

• Brand Name: ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT
• Type of Device: HSX
• 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: 5570268
• MDR Text Key: 43014461
• Report Number: 1822565-2016-01153
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/08/2014

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: 00584201602
• Device Lot Number: 62068135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2012
• 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
• Patient Age: 60 YR