MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH AVON PATELLA SMALL; IMPLANT

Catalog Number 64300020

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/17/2014

Event Type  Injury  

Event Description

It was reported that patient had bilateral knee revision surgery because avon patellas failed.Surgeon revised patient to triathlon patellas.(right).(b)(4) 2014: the sales rep confirmed that the patient had a revision of the right and left patellas on (b)(6) 2014 due to aseptic loosening.The right patella explanted was an avon.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Retained by patient.

Manufacturer Narrative

Corrected data: device manufacture date.An event regarding component loosening involving a avon patellar component was reported.The event was not confirmed.Method & results: the device was not returned for evaluation no bilateral primary patellofemoral operative reports, no bilateral first revision operative reports, and no documentation of the implanted components and whether the avon patellar components were retained at the time of the bilateral revision to total knee arthroplasties are available.There are no readable serial x-rays or no examination of the explanted components available.There is no confirmation of mechanical loosening of the patellar components or if they were articulating properly with the femoral components of the total knee arthroplasties.There is no evidence that this patient¿s clinical problems were the result of factors of faulty component design, manufacturing or materials.The device was manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information has been received.The medical review indicates that there are no primary or revision operative reports and no documentation of the implanted components and also no indication whether the avon patellar components were retained at the time of the bilateral revision to total knee arthroplasties.There are no readable serial x-rays or no examination of the explanted components available.The medical review further indicates that there is no confirmation of mechanical loosening of the patellar components or if they were articulating properly with the femoral components of the total knee arthroplasties.There is no evidence that this patient¿s clinical problems were the result of factors of faulty component design, manufacturing or materials.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that patient had bilateral knee revision surgery because avon patellas failed.Surgeon revised patient to triathlon patellas.(right).On (b)(6) 2014: the sales rep confirmed that the patient had a revision of the right and left patellas on (b)(6) 2014 due to aseptic loosening.The right patella explanted was an avon.

• Brand Name: AVON PATELLA SMALL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4322632
• MDR Text Key: 21338293
• Report Number: 0002249697-2014-04641
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2009
• Device Catalogue Number: 64300020
• Device Lot Number: LH202
• Other Device ID Number: STER. LOT E4124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 91