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-400

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

Patient Problem Injury (2348)

Event Date 01/25/2010

Event Type  Injury  

Manufacturer Narrative

An event regarding femoral and baseplate component malposition leading to insert ps post fracture involving a triathlon baseplate component was reported.The event was confirmed.Device evaluation and results: not performed as no device was returned.Medical records received and evaluation: clinician review of this case indicated combined femoral and tibial baseplate malposition resulting in an oblique joint line of some 5° has contributed to an overload condition in the post/cam mechanism of the ps arthroplasty resulting in a fatigue fracture after 6-years.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.Clinician review of this case indicated combined femoral and tibial baseplate malposition resulting in an oblique joint line of some 5 degrees has contributed to an overload condition in the post/cam mechanism of the ps arthroplasty resulting in a fatigue fracture after 6-years.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Remained implanted.

Event Description

A patient underwent a knee surgery, with implantation of a triathlon ps.On (b)(6) 2016 a revision has been performed due the breakage of the insert (post).Tibial and femoral components added on (b)(6) 2016 due to malpositioning mentioned in medical review, therefore, they will both be reported under mdr.

• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5944193
• MDR Text Key: 54500683
• Report Number: 0002249697-2016-02907
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 5520-B-400
• Device Lot Number: SPACX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2009
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 92