MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT

Catalog Number 6197-9-001

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408)

Patient Problems Fall (1848); Injury (2348); Inadequate Osseointegration (2646)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate ten packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A review of the medical records by a clinician indicated: ¿on (b)(6) 2016 a revision of the left total knee femoral and tibial components was performed for a post-operative diagnosis of: loose femoral component; partial loose tibial component and; intact patellar component.[¿] femur easily removed ¿ no significant attachment to femoral bone ¿ came off with cement still attached to metal.Tibia not well attached laterally but good attachment medially ¿ removed ¿ patella intact and retained.[¿] on (b)(6) 2015 an ap, lateral and oblique of the left knee demonstrates a cemented total knee arthroplasty with minimal cement visualized around the femoral and tibial components and with none visualized around the tibial keel or the femoral pegs.X-rays dated (b)(6) 2016 are ap and lateral of the left knee and leg length views show no gross migration of the knee, but the leg length indicates the knee is in approximately 5° of varus with a radiolucency around the tibial keel and anterior femoral component." the clinician concluded, "inadequate cement technique in this large, active man resulted in apparent loosening at the cement/bone interface.Since cement is not glue, adhesion is related to creating a large surface area at the bone interface to maintain fixation.No prosthesis related factors are shown to be involved in the post revision reported pain.There is no evidence that factors of faulty component or cement design, manufacturing or materials were responsible for this clinical situation." the investigation concluded that loosening was caused by inadequate cement technique.There is no evidence that factors of faulty component or cement design, manufacturing or materials were responsible for this clinical situation.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient reported his left knee primary surgery was done in approximately (b)(6) 2015.He would walk and fall.The surgeon stated that there was too much movement in the implant.He indicated that it was loose and revised the patient on (b)(6) 2016.Primary surgery had stryker products and revision surgery had stryker products.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Type of Device: BONE CEMENT
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6358794
• MDR Text Key: 68348866
• Report Number: 0002249697-2017-00675
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2017

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: 05/31/2016
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MJV082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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: 54 YR
• Patient Weight: 129