MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530G211

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Injury (2348); Ambulation Difficulties (2544)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: unknown simplex; cat# unknown; lot# unknown.Triathlon prim cem fxd bplt #2; cat# 5520-b-200; lot# sxkcp.Triathlon cr fem comp #2 r-cem; cat# 5510-f-202; lot# unknown.Triathlon asymmetric x3 patella; cat# 5551-g-320; lot# a470.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 a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Patient has been experiencing weakness when going up and down steps, a bit of instability, and pain.She states she has a limp when walking and it feels like there are pockets of fluid in her knee.Patient had a left knee replacement in (b)(6) 2010.Patient wants to know if her implants were ever recalled.Update as per patient on (b)(6) 2016 as reflected in communication log: this patient has not had a revision.

Manufacturer Narrative

The unknown simplex reported in the initial report was updated to simplex p with tobramycin 1 pack cat# 6197-9-001 lot# mkq074 qty.2.An event regarding instability involving a triathlon insert component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation, it remains implanted.-medical records received and evaluation: clinician review of the medical records provided indicated that cr implantation in a pcl deficient knee has contributed to complaints of pain, instability and weakness of the left replaced triathlon knee while subjective overload of the right knee has likely contributed to similar complaints of the right knee.A lot of uncertainty exists regarding these assumptions through lack of adequate information, especially x-rays although very well possible and plausible from the clinical perspective.More information would be required to solve this case with more certainty.-device history review: review of the dhr was satisfactory.-complaint history review: review of the complaint history confirmed that there were no other similar reported events for the lot.Conclusions: clinician review of the medical records provided indicated that cr implantation in a pcl deficient knee has contributed to complaints of pain, instability and weakness of the left replaced triathlon knee while subjective overload of the right knee has likely contributed to similar complaints of the right knee.A lot of uncertainty exists regarding these assumptions through lack of adequate information, especially x-rays although very well possible and plausible from the clinical perspective.More information would be required to solve this case with more certainty.Further information such as x-rays and well as further patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Patient has been experiencing weakness when going up and down steps, a bit of instability, and pain.She states she has a limp when walking and it feels like there are pockets of fluid in her knee.Patient had a left knee replacement in (b)(6) 2010.Patient wants to know if her implants were ever recalled.Update as per patient on 5/11/2016: this patient has not had a revision.

• Brand Name: X3 TRIATHLON INSERT CR#2 11MM
• 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: 5683093
• MDR Text Key: 46064932
• Report Number: 0002249697-2016-01744
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 5530G211
• Device Lot Number: LBY183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2010
• 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: 82