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 01/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.Visual and photo inspection confirmed that the plastic packaging was stuck to the femoral implant in several locations.Further investigation revealed that the femoral component was packaged with a raw material lot of polyethylene bags that was previously identified as having the potential to adhere to highly polished surfaces.Independent lab testing has confirmed that the residue is non-toxic.Biocompatibility testing has determined that there exists a negligible risk to the patient associated with the reported issue.The lot was manufactured on 18 may 2012.The device was used for treatment.No other complaints have been received for this product/lot.Many factors have been identified that lead to the sticky bag occurrence, such as the size of the implant, the time of the year the product was packaged and the material formulation of the polyethylene bags.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 was reported that when the implant package was opened during surgery, the plastic packaging bag was stuck to the femoral prosthesis.Surgery was completed with another implant.There was a ten 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: 5569571
• MDR Text Key: 42974995
• Report Number: 1822565-2016-01179
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 62062081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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