MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problems Material Discolored (1170); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

While revising the triathlon tkr and on removal of the polyethylene insert, it was noted that is had yellow discolouration on the articulating surface.The poly had only been i situ for 9 months.The insert was replaced along with the femoral component.The revision was due to malalignment of components.

Manufacturer Narrative

The device was not returned for evaluation.An event regarding malposition involving a triathlon femoral component was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the components were not returned.Medical records received and evaluation: component malposition with valgus deformity across the knee has contributed to abnormal biomechanics with patellar subluxation and cosmetically disturbing appearance of the knee requiring revision.Because on the standing long leg x-ray the joint space is still horizontal, the cause of the malposition is in the femoral component.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: clinician review of this case indicated component malposition with valgus deformity across the knee has contributed to abnormal biomechanics with patellar subluxation and cosmetically disturbing appearance of the knee requiring revision.Because on the standing long leg x-ray the joint space is still horizontal, the cause of the malposition is in the femoral component.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

While revising the triathlon tkr and on removal of the polyethylene insert, it was noted that is had yellow discolouration on the articulating surface.The poly had only been i situ for 9 months.The insert was replaced along with the femoral component.The revision was due to malalignment of components.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5997350
• MDR Text Key: 56392828
• Report Number: 0002249697-2016-03159
• Device Sequence Number: 1
• Product Code: MBH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 5510F501
• Device Lot Number: EJ9DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 78