MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Synovitis (2094)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient reported a "clean out" of his right knee due to infection.It is unknown if any components were exchanged.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon prim cem fxd bplt #5; cat# 5520b500; lot# atr6k triathlon asymmetric x3 patella; cat# 5551-g-381 ; lot# t8vp triathlon ps fem component, cemented; cat# 5515-f-502; lot# tsswtuu3 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of medical records by clinical consultant indicated: this inquiry reports a total knee replacement that subsequently became infected and was re-operated approximately 1 1/2 years after implantation.While no other information is provided in this particular inquiry, there are associated inquiries which document further surgeries including two-stage revision, arthrodesis, and subsequent amputation.I can confirm that these events occurred since i was able to review records documenting procedures.Regarding the root cause of infection following total knee arthroplasty 1 1/2 years after implantation, i cannot determine it with certainty.The causes are multifactorial including surgical actors and patient factors.Most commonly late infection occurs because of seeding of the arthroplasty from a remote site.As outlined above, this inquiry concerns a total knee replacement which became infected requiring subsequent surgeries which eventually led to an amputation of the right lower extremity.The causes of persistent infection following multiple surgeries after a total knee arthroplasty are multifactorial including surgical factors and patient factors and commonly due to seeding from a remote site.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of medical records by clinical consultant indicated: this inquiry reports a total knee replacement that subsequently became infected and was re-operated approximately 1 1/2 years after implantation.While no other information is provided in this particular inquiry, there are associated inquiries which document further surgeries including two-stage revision, arthrodesis, and subsequent amputation.I can confirm that these events occurred since i was able to review records documenting procedures.Regarding the root cause of infection following total knee arthroplasty 1 1/2 years after implantation, i cannot determine it with certainty.The causes are multifactorial including surgical actors and patient factors.Most commonly late infection occurs because of seeding of the arthroplasty from a remote site.As outlined above, this inquiry concerns a total knee replacement which became infected requiring subsequent surgeries which eventually led to an amputation of the right lower extremity.The causes of persistent infection following multiple surgeries after a total knee arthroplasty are multifactorial including surgical factors and patient factors and commonly due to seeding from a remote site.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.No further information is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Patient reported a "clean out" of his right knee due to infection.It is unknown if any components were exchanged.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of medical records by clinical consultant indicated: this inquiry reports a total knee replacement that subsequently became infected and was re-operated approximately 1 1/2 years after implantation.While no other information is provided in this particular inquiry, there are associated inquiries which document further surgeries including two-stage revision, arthrodesis, and subsequent amputation.I can confirm that these events occurred since i was able to review records documenting procedures.Regarding the root cause of infection following total knee arthroplasty 1 1/2 years after implantation, i cannot determine it with certainty.The causes are multifactorial including surgical actors and patient factors.Most commonly late infection occurs because of seeding of the arthroplasty from a remote site.As outlined above, this inquiry concerns a total knee replacement which became infected requiring subsequent surgeries which eventually led to an amputation of the right lower extremity.The causes of persistent infection following multiple surgeries after a total knee arthroplasty are multifactorial including surgical factors and patient factors and commonly due to seeding from a remote site.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of medical records by clinical consultant indicated: this inquiry reports a total knee replacement that subsequently became infected and was re-operated approximately 1 1/2 years after implantation.While no other information is provided in this particular inquiry, there are associated inquiries which document further surgeries including two-stage revision, arthrodesis, and subsequent amputation.I can confirm that these events occurred since i was able to review records documenting procedures.Regarding the root cause of infection following total knee arthroplasty 1 1/2 years after implantation, i cannot determine it with certainty.The causes are multifactorial including surgical actors and patient factors.Most commonly late infection occurs because of seeding of the arthroplasty from a remote site.As outlined above, this inquiry concerns a total knee replacement which became infected requiring subsequent surgeries which eventually led to an amputation of the right lower extremity.The causes of persistent infection following multiple surgeries after a total knee arthroplasty are multifactorial including surgical factors and patient factors and commonly due to seeding from a remote site.Patient would like to know if his implants were involved in a recall.As device lot code was not provided, it is not possible to determine if the patient¿s implant is subject to a recall.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 or Problem Description
Patient reported a "clean out" of his right knee due to infection.It is unknown if any components were exchanged.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14545713
• Report Number: 0002249697-2022-00783
• Device Sequence Number: 6774085
• Product Code: MBH
• UDI-Device Identifier: 07613327050783
• UDI-Public: 07613327050783
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5532-G-511
• Device Catalogue Number: 5532-G-511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 10/25/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/29/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 DA
• Patient Sex: Male
• Patient Weight: 84 KG