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

Catalog Number 64300100

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 01/01/2010

Event Type  Injury  

Event Description

It was reported that the patient hears lots of popping and scratching sound like metal in both left and right knee.Patient also has pain time to time in both knees.He is concerned if his implant is part of the recall process.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown stryker right knee.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device remains implanted.

Manufacturer Narrative

The following item was added to the complaint after the initial medwatch was submitted.Cat.No.: 6479-4-911, kx+ duration patella med, lot code: lbe516.The patient is (b)(6) in height.An event regarding pain involving an avon patella-femoral component was reported.The event was confirmed.The device remains implanted.Medical records received and evaluation: medical review concluded that there is no documentation of a recall of these components.Other than the follow-up description of excellent range of motion, good positioning, and ¿mild patella femoral crepitus¿ there is no documented confirmation of the complaints noted in the event description.There is no follow-up subsequent to (b)(6) 2011 and no evidence of factors of faulty prosthetic design, manufacturing, or materials responsible for this clinical situation.Device history review: dhr review was satisfactory.Complaint history review: there have been no other similar reported events for the lot referenced.Conclusions: the reported pain was confirmed through the medical records provided.The medical review indicated that the patient had excellent range of motion and the components position was good.There is no evidence of factors of faulty prosthetic design, manufacturing, or materials responsible for this clinical situation.The exact cause of the reported pain could not be determined with the information provided.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.

Event Description

It was reported that the patient hears lots of popping and scratching sound like metal in both left and right knee.Patient also has pain time to time in both knees.He is concerned if his implant is part of the recall process.

• Brand Name: AVON PAT/FEM JOINT SML
• 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 NJ 07430 NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3753462
• MDR Text Key: 4548857
• Report Number: 0002249697-2014-01250
• Device Sequence Number: 1
• Product Code: KRR
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 64300100
• Device Lot Number: SPS4L
• Other Device ID Number: STERILE LOT: KB114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2009
• 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): Other
• Patient Age: 35 YR
• Patient Weight: 122