MAUDE Adverse Event Report: ZIMEMR INC NEXGEN ALL POLY PATELLA PROVISIONAL

Catalog Number 00597106535

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091); Foreign Body In Patient (2687)

Event Date 10/30/2012

Event Type  Injury  

Event Description

It is reported that the pt was revised due to pain and swelling.During the revision surgery it was discovered that the patella trial implant had been left in the pt.

Manufacturer Narrative

No devices or photos were received; therefore, the condition of the instrument is unk.All print revision levels for the instruments were reviewed, and found to require etching of "not for implant" on the instrument.It is made from gray colored polyetherimide indicating different visual quality from implantable patellas.Primary operative notes received state the trial implants were removed, and the patella was cemented into place after the femoral and tibial components were implanted.Additionally, it was stated that final patella tracking was checked prior to closure.Revision surgical notes were not provided.Complaint history search found no other reports of this nature for this instrument family.As this is not an implantable material, wear properties in situ under these conditions would not be not.Infection may be caused by debris.Root cause for this event appears to be the implantation of an instrument provisional, rather than the final, implantable component.The part and lot numbers are unk; therefore the device history records could not be reviewed.

• Brand Name: NEXGEN ALL POLY PATELLA PROVISIONAL
• Manufacturer (Section D): ZIMEMR INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3877687
• MDR Text Key: 21804012
• Report Number: 1822565-2014-00676
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00597106535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR