MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G416

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: unknown triathlon #4 femoral tibial component ; cat#unknown; lot#unknown.Unknown 32 mm patella component; cat#unknown; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported by the patient that she started experiencing pain, swelling and burning sensation from her knee to her toe after her left tka.Patient stated her neurologist diagnosed her with reflex sympathetic dystrophy (rsd).

Event Description

It was reported by the patient that she started experiencing pain, swelling and burning sensation from her knee to her toe after her left tka.Patient stated her neurologist diagnosed her with reflex sympathetic dystrophy (rsd).

Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella; cat#5551-g-320;lot#43a5 triathlon cr fem comp #4 l-cem; cat#5510f401; lot#ax24t triathlon prim tib baseplate - cemented; cat#5520-b-400; lot#tthla simplex p - us full dose 10-pk; cat#61911010; lot#rbx023 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information: section d and section g.An event regarding pain involving an triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿the event description notes, ¿patient stated ¿ pain, swelling and burning sensation from the knee to her toe after left total knee arthroplasty ¿ her neurologist diagnosed her with reflex sympathetic dystrophy.¿¿ x-rays dated (b)(6)2018 demonstrate a nominal left total knee arthroplasty without evidence of pathology.Reflex sympathetic dystrophy occurs after trauma or surgery and is not related to implant design, manufacturing or materials, and is often treated with lumbar sympathetic blocks.¿ medical review addendum: ¿review of this additional documentation does not alter the conclusions of my earlier report.¿ -product history review: review of the product history records indicates 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: the exact cause of the reported pain could not be determined.A review of the provided records by a clinical consultant indicated there is no evidence the event is device related.It was noted in the operative report that the patient¿s neurologist diagnostic her with reflex sympathetic dystrophy (rds).The clinician noted that this can happen after trauma or surgery and her condition is not related to the devices that were implanted.The patient has inquired if her devices are a part of a recall.Our regulatory department reviewed all of her implant catalog and lot codes and they are not a part of any recall.Additional records were received, and a medical review addendum was created.The clinician noted that the additional medical records received did not change the conclusion on the earlier report.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

• Brand Name: X3 TRIATHLON CS INS SIZE4 16MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7374577
• MDR Text Key: 103593841
• Report Number: 0002249697-2018-00905
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 5531G416
• Device Lot Number: LES234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 113