MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B200

Device Problem Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 09/26/2018

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 reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

As reported: "[patient] had her [right] knee replaced in march.Her tibial component had subsided on the medial side after a fall.[surgeon] removed her knee implants and converted to a ts knee.

Manufacturer Narrative

An event regarding subsidence involving a tritanium baseplate was reported, the event was not confirmed however, periprosthetic fracture around a tritanium triathlon baseplate due to patient fall was noted.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated a fall of a morbidly obese patient at 6-months post surgery has contributed to a periprosthetic fracture around a tritanium triathlon baseplate requiring knee revision surgery.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated a fall of a morbidly obese patient at 6-months post surgery has contributed to a periprosthetic fracture around a tritanium triathlon baseplate requiring knee revision surgery.The exact cause of the event could not be determined as insufficient information was provided.Further information such as revision operative notes, office/clinical notes, histopathology, serial x-rays and examination of the explanted devices are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "[patient] had her [right] knee replaced in march.Her tibial component had subsided on the medial side after a fall.[surgeon] removed her knee implants and converted to a ts knee.

• Brand Name: TRITANIUM BPLATE TRIATHLON S2
• 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: 8001485
• MDR Text Key: 124880983
• Report Number: 0002249697-2018-03484
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041590
• UDI-Public: 07613327041590
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 5536B200
• Device Lot Number: CTD13282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 106