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

Model Number 5531-G-409

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Fall (1848); Loss of Range of Motion (2032)

Event Date 10/23/2013

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.

Event Description

Information received includes a report dated (b)(6) 2013: "unfortunately, she had a fall a week back and since then her knee has been swollen.With regards to her hemarthrosis, we proceeded to aspirate out about 70 cc of blood from her knee joint under all aseptic precautions.".

Event Description

Information received includes a report dated on (b)(6) 2013: "unfortunately, she had a fall a week back and since then her knee has been swollen.With regards to her hemarthrosis, we proceeded to aspirate out about 70cc of blood from her knee joint under all aseptic precautions.".

Manufacturer Narrative

Reported event: an event regarding patient factors involving a triathlon insert was reported.The event of aspiration was confirmed by medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinical review: review of the provided medical records by a clinical consultant indicated: revision surgery was performed on (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 the patient presented to the office 15 days postoperatively, on blood thinners with a red swollen knee.The patient returned after having a fall.Knee motion was somewhat decreased to 0-95°, her knee had been swollen and the extensor mechanism appeared intact.Another aspiration (70 cc of blood) was performed with another injection.Hazards: none clearly related to implant.Conclusion of assessment: the aspirations events were also confirmed.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 4 other similar events for the reported lot related to the same device / patient.Conclusions: review of the provided medical records by a clinical consultant indicated: the patient returned after having a fall.Her knee had been swollen and the extensor mechanism appeared intact.Aspiration (70 cc of blood) was performed.Hazards: none clearly related to implant.The aspirations events were confirmed.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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
• MDR Report Key: 10173123
• MDR Text Key: 195709651
• Report Number: 0002249697-2020-01235
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: 07613327045802
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 5531-G-409
• Device Catalogue Number: 5531G409
• Device Lot Number: LCP991
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 104