MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G409

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# tovdb.Triathlon asym patella a32x10; cat# 5551-l-320; lot# lew136.Tri rm/ll tib aug sz4 10mm; cat# 5546-a-402; lot# er9hd9a.Triathlon cr fem comp #4 r-cem; cat# 5510f402; lot# el48b.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 remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in the supplemental report upon completion of the investigation.Remains implanted.

Event Description

Pain and loosening of his knee component after revision.The patient underwent a revision of his right medial uni-compartment to a right total knee arthroplasty on (b)(6) 2016.He further alleges that he continues to have pain and loosening of his knee component.He scheduled for a second revision (b)(6) 2017.

Manufacturer Narrative

An event regarding loosening involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the product was not returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have been no other similar reported events for the lot referenced.Conclusions: the exact cause of the reported loosening could not be determined with the limited information provided.Further information such as product return, x-rays, operative notes, medical records and follow-up notes are needed to complete the investigation to determine a root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Pain and loosening of his knee component after revision.The patient underwent a revision of his right medial uni-compartment to a right total knee arthroplasty on (b)(6) 2016.He further alleges that he continues to have pain and loosening of his knee component.He scheduled for a second revision (b)(6) 2017.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• 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: 6315007
• MDR Text Key: 66918267
• Report Number: 0002249697-2017-00513
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: (01)07613327045802(11)160211(17)210228(10)LEW997
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5531G409
• Device Lot Number: LEW997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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: 50 YR
• Patient Weight: 91