MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #2 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F201

Device Problem Insufficient Information (3190)

Patient Problem Weakness (2145)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

This pi is for weakness after revision surgery on left knee.Patient called stating she had bilateral knee replacements done on (b)(6) 2019.Her left knee was revised on (b)(6) 2019 due to femoral subsidence.She also mentioned she is experiencing weakness after her revision surgery.Patient stated she is not having issues with her right knee.

Manufacturer Narrative

Updated product information and contact information.Reported event an event regarding patient factors involving a triathlon femoral component was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the revision surgery was performed on (b)(6) 2019.The operative report noted that the femoral component was removed using an oscillating saw and moreland osteotome without appreciable bone loss.This implied that the implant was well fixed.The distal femur was recut using an intramedullary guide set to 7°.It was noted that the cut removed more bone medially than laterally which indicated that the preoperative increased valgus angle was being corrected.The rest of the femur was re-cut with a 4 in 1 cutting guide referencing the anterior femoral cortex via 2 static saw blades.The femur was cut to a size #2.A cruciate retaining femoral component had reasonable fit but the implant was cemented due to a concern that some of the bone had been stress shielded and was soft.After the cement hardened, a 14 mm x3 tibial bearing was inserted.The implant sizes were confirmed on the implant sheet provided.No complications were noted.The postoperative x-ray report was read as satisfactory positioning and alignment of prosthetic components with an impression of satisfactory post-op appearance of the left knee.As noted, a postoperative internal medicine consultation was obtained for postoperative management.The physical exam, laboratory exam and physician assessment did not reveal any concerns.The patient's preoperative status and comorbidities were similar to those at her primary procedure.No additional clinical information or postoperative course were provided.However the pi reports indicated dissatisfaction due to due to weakness of the left knee after the revision surgery.Conclusion of assessment: revision of the femoral component was confirmed.One cannot confirm the complaint of post-operative weakness without physical assessment." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there has been no other similar event for the lot referenced.Conclusions: it was reported that the patient had weakness after the revision surgery.The available medical records were provided to the consulting clinician for a review which was deemed insufficient to confirm the event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as postmortem report, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

This pi is for weakness after revision surgery on left knee patient called stating she had bilateral knee replacements done on (b)(6) 2019.Her left knee was revised on (b)(6) 2019 due to femoral subsidence.She also mentioned she is experiencing weakness after her revision surgery.Patient stated she is not having issues with her right knee.

• Brand Name: TRIATHLON CR FEM COMP #2 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
• MDR Report Key: 9775446
• MDR Text Key: 187013078
• Report Number: 0002249697-2020-00423
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 5510F201
• Device Lot Number: D676B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR