MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_A SIZE 4 TRIATHLON FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/14/2014

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.

Event Description

This pi is for the third revision surgery on (b)(6) 2014 due to painful left total knee replacement and a loose femoral component.This event was reported in medical review.

Manufacturer Narrative

Reported event; an event regarding loosening involving an unknown triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: patient underwent primary right total knee arthroplasty in 2009 that failed in 2011, with lysis of adhesions and poly exchange.That revision surgery failed again due to loosening and the patient had another revision in 2013.That surgery also failed due to loosening.I can confirm that the events occurred since i was able to review the operation reports, office notes and i reviewed pre op and post op x-rays.Regarding the possible root cause of this event, i cannot determine this for certain.I don¿t see any abnormality with the implants.Loosening is a well-known complication.Operative technique, soft tissue balancing and cementing technique are key in the longevity of a total knee replacement.Failures in revision and re-revision surgery can also be attributed to surgical technique and prosthetic selection (augments, gap balancing, restoration of joint line, etc.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's knee was revised due to painful left total knee replacement and a loose femoral component whereby the femoral component, tibial component and the patella component were revised.Clinician review of provided medical review indicated that the second revision "surgery also failed due to loosening".Loosening is a well-known complication.Operative technique, soft tissue balancing and cementing technique are key in the longevity of a total knee replacement.Failures in revision and re-revision surgery can also be attributed to surgical technique and prosthetic selection (augments, gap balancing, restoration of joint line, etc.The exact cause of the event could not be determined.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.

Event Description

This pi is for the third revision surgery on (b)(6) 2014 due to painful left total knee replacement and a loose femoral component.This event was reported in medical review.

• Brand Name: UNKNOWN_A SIZE 4 TRIATHLON FEMORAL COMPONENT
• 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: 12279752
• MDR Text Key: 265134653
• Report Number: 0002249697-2021-01309
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 100