MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; IMPLANT

Catalog Number 6191-1-001

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)

Event Date 05/04/2011

Event Type  Injury  

Event Description

It was reported that the patient was revised with a stryker experimental knee.The patient is experiencing pain all the time, her leg is crooked and she needs assistance to walk.Patient wants to know if her products are part of a recall.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown right stryker 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 patient is (b)(6) inches in height.An event regarding pain involving simplex p bone cement was reported.The event was not confirmed.The device remains implanted.Medical records received and evaluation: the only stryker component used was (b)(6) units of simplex p bone cement.There is no evidence that factors of faulty stryker cement is responsible for this clinical situation.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the reported pain could not be determined based on the limited information provided, however there is no evidence the event is device related.It is noted that the subject device is not part of a recall.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 was revised with a stryker experimental knee.The patient is experiencing pain all the time, her leg is crooked and she needs assistance to walk.Patient wants to know if her products are part of a recall.

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• 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: 3764477
• MDR Text Key: 4547527
• Report Number: 0002249697-2014-01481
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062553
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RLR187
• Other Device ID Number: STERILE LOT: 45SKR1
• 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: 12/09/2010
• 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: 76 YR
• Patient Weight: 83