MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F702

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

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

Knee revised in 2021 index surgery december 2019.Planed femoral rotation, landmarks, & robot accuracy confirmation.Case type / application: tka.Update 11/august/2021 wg: as reported by mps: "surgeon that revised knee said ¿femoral component was horribly externally rotated.¿".

Event Description

Knee revised in 2021 index surgery (b)(6) 2019.Planed femoral rotation, landmarks, & robot accuracy confirmation.Case type / application: tka.Update 11/august/2021 wg: as reported by mps: "surgeon that revised knee said ¿femoral component was horribly externally rotated¿".

Manufacturer Narrative

Reported event: an event regarding malposition involving a triathlon femoral component was reported.The event 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 was not returned.A review of returned software session logs found the following.The session and vp log data from the case was reviewed.An analysis of the checkpoint check values, bone registration values, probe check values, rio registration and verification values, bone preparation checkpoints values, crisis warnings and errors, and cutting tool location was completed.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.The rio performed all five femoral planes on target based on centroid comparison, with minor rotational error, as indicated from the burrlist plane analysis.This does not indicate ¿horrible external rotation.¿ these measurements are only an estimation and are not to be considered as calibrated measurements.-clinician review: a review of the provided medical records by a clinical consultant indicated: re pi - which represents a male patient, dob (b)(6) 1951 whose date of implantation is listed as (b)(6) 2019 and explantation (b)(6) 2021.The event description states: ".Surgeon that revised knee said femoral component was horribly externally rotated." (b)(6) 2020 x-rays: ap and lateral right knee - right tka, no cement visible, patella not visible, tibial component appears nominal with true ap and lateral position on x-ray while the femoral component appears malrotated and in varus.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.While the x-rays appear to confirm the event description of a malrotated femoral component, insufficient data is presented to create a medical report for this case.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.

• Brand Name: TRIATHLON CR FEM COMP #7 R-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: 12384648
• MDR Text Key: 268696704
• Report Number: 0002249697-2021-01475
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 5510F702
• Device Lot Number: EJ26J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• 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: 75