MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-300

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales rep reported a left total knee revision due to pain.Sales rep was able to view the explanted devices and they had damage consistent with the process of explantation.The poly showed damage and the baseplate had some cement debris.

Manufacturer Narrative

An event regarding revision due to loosening involving a triathlon baseplate component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: implantation of triathlon ts devices with extreme loosening of a short-keel baseplate with cement fracture, radiolucent lines and osteolysis.The baseplate has severe migration with malalignment into varus and posterior tilt.The femoral component has no obvious issues, similar to the patellar device.Use of a short-keel baseplate in a maximum constrained ts construct caused overload in the tibial baseplate fixation section that by presence of a short-keel was unable to resist the big impact of a ts construct on the stabilizing requirements of such a device with limited anchoring surface and thus failed through fatigue in the bone cement.Device history review: not performed as lot details were not provided.Complaint history review: not performed as lot details were not provided.Conclusions: the medical review indicates that implantation of triathlon ts devices with extreme loosening of a short-keel baseplate with cement fracture, radiolucent lines and osteolysis.The baseplate has severe migration with malalignment into varus and posterior tilt.The femoral component has no obvious issues, similar to the patellar device.Use of a short-keel baseplate in a maximum constrained ts construct caused overload in the tibial baseplate fixation section that by presence of a short-keel was unable to resist the big impact of a ts construct on the stabilizing requirements of such a device with limited anchoring surface and thus failed through fatigue in the bone cement the exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details, device return, dated pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Sales rep reported a left total knee revision due to pain.Sales rep was able to view the explanted devices and they had damage consistent with the process of explantation.The poly showed damage and the baseplate had some cement debris.

• Brand Name: TRI TS BASEPLATE SIZE 3
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6602968
• MDR Text Key: 76372659
• Report Number: 0002249697-2017-01742
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5521-B-300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR