MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-501

Device Problems Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408); Unintended Movement (3026)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Date 01/18/2011

Event Type  Injury  

Manufacturer Narrative

An event regarding osteolysis, migration and incorrect selection involving a triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: 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.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that at surgery they found that the femoral component was slightly elevated anteriorly and may have resulted in narrowing the patellofemoral space.They removed the femoral component and there was some bone loss laterally and anteriorly and posteriorly.They found on the medial side the posterior condyle had not been fully resected and they downsized to a size 4.The event was confirmed via clinician review.The exact cause of the event could not be determined.If further information becomes available or the product is returned, this investigation will be re-opened.Not returned.

Event Description

It was reported that; after revision surgery, patient states that he continues to experience pain and swelling on left knee.Patient has had bone scans and is currently following up with surgeon as he states his knee feels loose.*update on 16-aug-2021: this pi is for the second revision on (b)(6) 2013.Per medical review, "the patient underwent a second revision on (b)(6) 2013 with a diagnosis of a painful unstable left total knee arthroplasty.At surgery they found that the femoral component was slightly elevated anteriorly and may have resulted in narrowing the patellofemoral space.They removed the femoral component there was some bone loss laterally and anteriorly and posteriorly, they found on the medial side the posterior condyle had not been fully resected and they downsized to a size 4.The tibial component was also loose.The patella had a scratch on it and they removed it.They then cemented a triathlon size 4 universal base plate and cemented a triathlon x3 symmetrical 9 mm thick patella.They used a size 4 ¿ 16mm total stabilized poly insert.".

Manufacturer Narrative

Corrected data: date of implant.

Event Description

It was reported that; after revision surgery, patient states that he continues to experience pain and swelling on left knee.Patient has had bone scans and is currently following up with surgeon as he states his knee feels loose.Update on 16-aug-2021: this pi is for the second revision on (b)(6) 2013.Per medical review, "the patient underwent a second revision on (b)(6) 2013 with a diagnosis of a painful unstable left total knee arthroplasty.At surgery they found that the femoral component was slightly elevated anteriorly and may have resulted in narrowing the patellofemoral space.They removed the femoral component there was some bone loss laterally and anteriorly and posteriorly, they found on the medial side the posterior condyle had not been fully resected and they downsized to a size 4.The tibial component was also loose.The patella had a scratch on it and they removed it.They then cemented a triathlon size 4 universal base plate and cemented a triathlon x3 symmetrical 9 mm thick patella.They used a size 4 ¿ 16mm total stabilized poly insert.".

Event Description

It was reported that; after revision surgery, patient states that he continues to experience pain and swelling on left knee.Patient has had bone scans and is currently following up with surgeon as he states his knee feels loose.*update on 16-aug-2021: this pi is for the second revision on (b)(6) 2013.Per medical review, "the patient underwent a second revision on (b)(6), 2013 with a diagnosis of a painful unstable left total knee arthroplasty.[.] at surgery they found that the femoral component was slightly elevated anteriorly and may have resulted in narrowing the patellofemoral space.They removed the femoral component there was some bone loss laterally and anteriorly and posteriorly, they found on the medial side the posterior condyle had not been fully resected and they downsized to a size 4.The tibial component was also loose.The patella had a scratch on it and they removed it.[.] they then cemented a triathlon size 4 universal base plate and cemented a triathlon x3 symmetrical 9 mm thick patella.They used a size 4 ¿ 16mm total stabilized poly insert.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: -device evaluation and results: could not be performed as the subject device was not returned.-medical records received and evaluation: 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.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that at surgery they found that the femoral component was slightly elevated anteriorly and may have resulted in narrowing the patellofemoral space.They removed the femoral component and there was some bone loss laterally and anteriorly and posteriorly.They found on the medial side the posterior condyle had not been fully resected and they downsized to a size 4.The event was confirmed via clinician review.The exact cause of the event could not be determined.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON CR FEM COMP #5 L-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: 12444878
• MDR Text Key: 270535658
• Report Number: 0002249697-2021-01526
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: 5510-F-501
• Device Catalogue Number: 5510F501
• Device Lot Number: SNJ7K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 09/17/2021
• Supplement Dates FDA Received: 09/13/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100