MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515-F-501

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Synovitis (2094); Injury (2348)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were added to this report after submission of the initial report: triathlon prim cem fxd bplt #5; cat# 5520b500; lot# elldb, triathlon symmetric x3 patella; cat# 5550-g-339; lot# e94r, triathlon ps x3 tibial insert; cat# 5532-g-511; lot# mnpl53, simplex p full dose 1 pack; cat# 6191-1-001; lot# rbv026.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.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

Patient had an arthroplastic procedure done in (b)(6) 2015.The patient continues to have swelling and pain 6 months after his arthroscopy.

Manufacturer Narrative

An event regarding pain involving a triathlon femoral component was reported.The event was confirmed.Medical records received and evaluation: the provided medical records were reviewed by a clinical consultant on (b)(6) 2016.The clinical consultant noted that there was improper surgical technique at insertion of prosthesis related to extruded cement which was removed arthroscopic on (b)(6) 2015.The patient continues to have pain and swelling one year after his index tka and 6 months after two large cementophytes were removed arthroscopically.Two consultants at hospital for special surgeries(hss) found no immediate cause of his pain and recommended continue observation.To date, the knee does not appear to have been aspirated to rule out infection.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: although the patient had arthroscopic removal of extruded simplex p cement on the lateral aspect of the prosthesis, the exact cause of the reported pain could not be determined and the reported pain continues and the patient will have continued observation.Based on the medical review by the clinical consultant there is no evidence that the persistent swelling and pain are causally related to the design, manufacture, or materials of this prosthesis, but more likely result from the surgical technique, which created the extruded cement, secondary surgery, and persistent synovitis.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient had an arthroplastic procedure done in (b)(6) 2015.The patient continues to have swelling and pain 6 months after his arthroscopy.

• Brand Name: TRIATHLON PS FEM COMPONENT, 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5398770
• MDR Text Key: 37106572
• Report Number: 0002249697-2016-00231
• 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
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 5515-F-501
• Device Lot Number: KTRYD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2014
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 88