MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Original knee tibial component was put in slight varus.Patient was complaining about pain.This was the patients left knee.

Manufacturer Narrative

An event regarding malposition involving a triathlon baseplate was reported.The event was confirmed through x rays provided.-device evaluation and results: not performed as the product was not returned.-medical records received and evaluation: revision of triathlon baseplate due to varus malposition some 5-months post arthroplasty in a (b)(6) year old male patient with near normal body weight (bmi = (b)(6)).The baseplate was exchanged for a universal baseplate with stem extender and 13-mm cs bearing.This patient had reportedly pain in the knee ever since time of implantation and this can certainly be attributed to the ligament unbalance in the knee causing overload with pain due to ligament and synovial tissue overstretch.This may cause gait problems as well.A significant malposition of knee components was thus present, especially the tibial baseplate in varus which was confirmed by physical examination prior to revision surgery as well as evident on the available x-rays.Because optimal component position is related to surgical technique under responsibility of the surgeon, principal failure mode is procedure-related without apparent patient-related or device-related matters present consistent with the type of failure.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: medical review concluded that component malposition with varus deformity of the baseplate causing pain contributed to revision surgery with baseplate and insert exchange.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Original knee tibial component was put in slight varus.Patient was complaining about pain.This was the patients left knee.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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 NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6350552
• MDR Text Key: 68065796
• Report Number: 0002249697-2017-00628
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327041057
• UDI-Public: (01)07613327041057(11)151008(17)201031(10)AMN8C
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 5520B500
• Device Lot Number: AMN8C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: 56 YR
• Patient Weight: 82