MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH AVON PAT/FEM JOINT MED; IMPLANT

Catalog Number 64300200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/20/2015

Event Type  Injury  

Event Description

Patients avon patella femoral replacement was revised for pain.It was replaced with a triathlon ps total knee.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Patient retained device.

Manufacturer Narrative

An event regarding revision for pain involving an avon femoral component was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: not performed as medical records were not provided.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have no other similar reported events for the lot referenced.Conclusions: pain - which was referenced in the event description - can occur post-operatively for a number of reasons but it is a symptom rather than the cause of the issue.The exact cause of the event could not be determined due to insufficient provision of information.Further information such as: return of reported devices, x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation to determine root cause.

Event Description

Patients avon patella femoral replacement was revised for pain.It was replaced with a triathlon ps total knee.

• Brand Name: AVON PAT/FEM JOINT MED
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4617616
• MDR Text Key: 5590345
• Report Number: 0002249697-2015-00778
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 64300200
• Device Lot Number: S73EM
• Other Device ID Number: STER. LOT N1116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• 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: 68 YR
• Patient Weight: 100