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)
Date of Event	01/01/2018
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 1st of 2 stage revision for infection where parts were removed and a spacer was implanted.
Event or Problem Description
Patient reported 1st of 2 stage revision for infection where parts were removed and a spacer was implanted.
Additional Manufacturer Narrative
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 was not returned.-clinician review: a review of medical records by clinical consultant indicated: "this inquiry reports the first of a two-stage revision for infection of a total knee arthroplasty.According to the information provided the initial implant was approximately (b)(6) 2016 and the date of explant was (b)(6) 2018.As described above this inquiry reports a totally arthroplasty which subsequently became infected and underwent a two-stage revision which was not successful and subsequent surgeries were necessary including arthrodesis of the knee and subsequent amputation of the lower extremity.I can confirm that these events happened since documentation is provided for the various surgeries.I am not able to determine the root cause with certainty.The root cause of persistent infection following totally arthroplasty is multifactorial including surgical factors, patient factors and usually results from seeding of the implant 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 the first of a two-stage revision for infection of a total knee arthroplasty.According to the information provided the initial implant was approximately (b)(6) 2016 and the date of explant was (b)(6) 2018.As described above this inquiry reports a totally arthroplasty which subsequently became infected and underwent a two-stage revision which was not successful and subsequent surgeries were necessary including arthrodesis of the knee and subsequent amputation of the lower extremity.I can confirm that these events happened since documentation is provided for the various surgeries.I am not able to determine the root cause with certainty.The root cause of persistent infection following totally arthroplasty is multifactorial including surgical factors, patient factors and usually results from seeding of the implant 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 investigation is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.Cat# 5520b500; triathlon prim cem fxd bplt #5; lot# atr6k.Cat# 5551-g-381; triathlon asymmetric x3 patella; lot# t8vp.Cat# 5515-f-502; triathlon ps fem component, cemented; lot# tsswtuu3.The following devices were also listed in this report: it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14520825
• Report Number: 0002249697-2022-00775
• Device Sequence Number: 6530307
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 84 KG