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

Catalog Number 00584201502

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not received for evaluation.The device history records were reviewed and found conforming to requirements at the time of manufacture.The low density polyethylene ldpe adhesion issue has been investigated and address by corrective and preventive actions.Health hazard evaluation evaluated the risk to the patient and found "risk assessment indicates that the likelihood of a toxic effect from the ldpe bags is negligible".Testing has been done that shows the residue can be removed with a cloth moistened with water or isopropyl alcohol.The lot was manufactured on august 3, 2012.The device was used for treatment.A product history search identified no other complaints for the specified part and lot combination.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 that when the femoral component was ordered opened during surgery, the implant was observed to have plastic adhered or melted to its surface.Holes were also observed in the plastic wrap where it had contact with the femur.The implant was cleaned and implanted.There was no report of 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: 5569678
• MDR Text Key: 42991782
• Report Number: 1822565-2016-01176
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/29/2014

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: 08/31/2021
• Device Catalogue Number: 00584201502
• Device Lot Number: 61857380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0845-2016
• Patient Sequence Number: 1
• Patient Age: 58 YR