MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-300

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Material Separation (1562); Loss of Osseointegration (2408); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Injury (2348); Inadequate Osseointegration (2646)

Event Date 12/14/2016

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.Not available.

Event Description

A cemented cr triathlon knee with a cs insert was revised for tibial baseplate loosening.Upon removal of the components it became apparent that a posterior portion of the tibial insert had fractured off in site.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed by medical review.Method and results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: medical review of the x-rays provided concluded that excessive posterior slope of baseplate has contributed to flexion instability of the arthroplasty causing overload on the posterior baseplate section that started to migrate in further posterior tilt due to the suboptimal cementation of the baseplate keel.A morbid obesity of the patient may have accelerated the loosening process with overload and fatigue fracture of the posterior baseplate section.-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 baseplate malposition has contributed to flexion instability causing posterior overload on the insert.This was further added to by increased posterior migration due to suboptimal cementation of the baseplate keel.The patient's morbid obesity may also have accelerated the baseplate loosening process and added to the overload and subsequent fracture of the insert.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

A cemented cr triathlon knee with a cs insert was revised for tibial baseplate loosening.Upon removal of the components it became apparent that a posterior portion of the tibial insert had fractured off in site.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6241031
• MDR Text Key: 64486178
• Report Number: 0002249697-2017-00170
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: (01)07613327050318(11)150305(17)200331(10)AAR3J
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 5520-B-300
• Device Lot Number: AAR3J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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: 65 YR
• Patient Weight: 132