MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #8; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B800

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Per patient, his 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 completed a left knee revision for the patient on (b)(6) 2016.Primary surgery had stryker products and revision surgery had stryker products.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: 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 (1) loose femoral component, (2) partial loose tibial component, and (3) 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." -device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that implant 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

Per patient, his 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 completed a left knee revision for the patient on (b)(6) 2016.Primary surgery had stryker products and revision surgery had stryker products.

Event Description

Per patient, his 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 completed a left knee revision for the patient on (b)(6) 2016.Primary surgery had stryker products and revision surgery had stryker products.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #8
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6107532
• MDR Text Key: 60072978
• Report Number: 0002249697-2016-03634
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 5520B800
• Device Lot Number: S6LFF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2011
• 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