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

Catalog Number 64300200

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/28/2015

Event Type  Injury  

Event Description

The patient's right knee was revised due to loosening of the femoral component.

Manufacturer Narrative

It was noted that no further information will be provided by the hospital/surgeon due to policy.A supplemental report will be submitted upon completion of the investigation.Hospital policy.

Manufacturer Narrative

An event regarding loosening involving an avon patella-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 were no other events for the reported lot.Conclusions: the exact cause of the event could not be determined due to insufficient provision of information.Further information such as: returned device, pre- and post-operative x-rays, primary and revision operative reports as well as patient history and follow-up notes are needed to complete the investigation to determine root cause.

Event Description

The patient's right knee was revised due to loosening of the femoral component.

• 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: 4551303
• MDR Text Key: 5523720
• Report Number: 0002249697-2015-00467
• 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: 01/28/2015

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: 07/31/2011
• Device Catalogue Number: 64300200
• Device Lot Number: SA39T
• Other Device ID Number: STER. LOT G7121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2006
• 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: 61 YR