MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH AVON PAT/FEM JOINT MED; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 64300200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested but not provided due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Bilateral knee revision.

Manufacturer Narrative

An event regarding revision for unspecified reasons involving an avon patello-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: review of the dhr for the lot was satisfactory.Complaint history review: there were no other similar reported events for the lot.Conclusions: the exact cause of the event could not be determined as insufficient information was provided.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 for determining a root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by (b)(4).If devices and / or additional information become available, this investigation will be reopened.

Event Description

Bilateral knee revision.

• Brand Name: AVON PAT/FEM JOINT MED
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5636626
• MDR Text Key: 44572392
• Report Number: 0002249697-2016-01536
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 64300200
• Device Lot Number: EB3FL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2013
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 92