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

Catalog Number 64300050

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "the patient experienced a lot of pain when standing up, sitting down, and when walking.The patella implant failed to track properly on the avon patellofemoral component.We converted into a primary ps triathlon knee".Rep reported that hospital would not release x-rays to stryker.

• Brand Name: AVON PAT/FEM JOINT EX SMALL
• 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: anna ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 8357503
• MDR Text Key: 136733333
• Report Number: 0002249697-2019-01112
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 07613327049305
• UDI-Public: 07613327049305
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2019

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: 09/30/2022
• Device Catalogue Number: 64300050
• Device Lot Number: CSH3E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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: 49 YR
• Patient Weight: 114