MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-316-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/13/2022
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: tri ts femur sz3 righte; cat# 5512-f-302 ; lot# ai33i; triathlon fem cone aug sz 3re; cat# 5549-a-332 ; lot# hnl3; tri ts baseplate size 3e; cat# 5521-b-300; lot# hzv4oa; triathlon stem extender 25mme; cat# 5571-s-025 ; lot# vn5988; tri cemented stem 12mmx50mme; cat# 5560-s-112 ; lot# 0115206a; tri press-fit stem 13x150mme; cat# 5566-s-013 ; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient presented with severe right tka pain and effusion.Workup for infection was positive.Patient opted for a 2-stage revision tka.
Event or Problem Description
Patient presented with severe right tka pain and effusion.Workup for infection was positive.Patient opted for a 2-stage revision tka.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.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 stated the following comment: as described above this patient sustained an infection after a primary total knee replacement approximately seven months after the index procedure.No history is given as to any contributory factors such as remote infection,immunosuppression, wound healing issues, etc.No definite root cause of this event can be determined.The causes of postoperative infection seven months after surgery are multifactorial.There could have been contamination at the time of the initial procedure, patient could have a remote area of infection which could have contaminated and seeded the implant.As i mentioned, no other information was given.The implant itself plays no role in postoperative infection if the implant was opened in a sterile fashion and there was no expiration of sterility, etc.-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 or sterile lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: as described above this patient sustained an infection after a primary total knee replacement approximately seven months after the index procedure.No history is given as to any contributory factors such as remote infection,immunosuppression, wound healing issues, etc.No definite root cause of this event can be determined.The causes of postoperative infection seven months after surgery are multifactorial.There could have been contamination at the time of the initial procedure, patient could have a remote area of infection which could have contaminated and seeded the implant.As i mentioned, no other information was given.The implant itself plays no role in postoperative infection if the implant was opened in a sterile fashion and there was no expiration of sterility, etc.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14674562
• Report Number: 0002249697-2022-00824
• Device Sequence Number: 20011676
• Product Code: MBH
• UDI-Device Identifier: 07613327288179
• UDI-Public: 07613327288179
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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 Expiration Date: 10/31/2024
• Device Model Number: 5537-G-316-E
• Device Catalogue Number: 5537-G-316-E
• Device Lot Number: 8M09A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White