MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G313

Device Problems Degraded (1153); Unstable (1667)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 12/02/2019

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.Not available.

Event Description

As reported: "event included in the reported submitted as proof of milestone for an investigator initiated study (b)(4).Per the report received 31/march/2020, indication for revision is pain and instability; femoral component and tibial liner revised.".

Event Description

As reported: "event included in the reported submitted as proof of milestone for an investigator initiated study (b)(6) 2018.Per the report received 31/march/2020, indication for revision is pain and instability; femoral component and tibial liner revised.".

Manufacturer Narrative

Reported event: an event regarding wear involving a tibial insert was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: revision surgery was performed (b)(6) 2013.The preoperative diagnosis was now failed knee arthroplasty with femoral component loosening and polyethylene liner wear.At the time of the revision the patellar component was found "completely floating in the knee".The femoral and tibial components were stable and well aligned.The patella was recut and a a3 5 x 10mm patella cemented in place.A new 9 mm cs polyethylene was placed.A lateral release and medial imbrication performed as well.No complications were reported from the surgery.Postoperative x-rays showed satisfactory appearance of the implants.The results from the intraoperative cultures were not provided, however the pathology did not show evidence of any acute inflammation.No significant additional data were contributory from the postoperative medicine consultation.Hazards: none clearly related to implant.Conclusion of assessment: the revision surgery was confirmed as were the two quadriceps repairs.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar event for the reported lot.Conclusion: a clinician review of the provided medical records states the following: at the time of the revision the patellar component was found "completely floating in the knee".The femoral and tibial components were stable and well aligned.Hazards: none clearly related to implant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

• Brand Name: X3 TRIATHLON CS INSERT #3 13MM
• 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: 10006440
• MDR Text Key: 189453496
• Report Number: 0002249697-2020-00817
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 5531G313
• Device Lot Number: LBE055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 74