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-409-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Fibrosis (3167)
Date of Event	02/14/2022
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.Device not returned.
Event or Problem Description
It has been reported "the sae happened on (b)(6) 2022.This patient had functional loss due to arthrofibrosis 8 weeks postoperatively.At (b)(6) 2022 the patient was hospitalized to perform manipulation under anesthesia.No explant or revision surgeries were done or planned.The event is related to the procedure (total knee arthroplasty), but we cannot say yet whether this is also related to this specific implant.".
Additional Manufacturer Narrative
Reported event: an event regarding rom/arthrofibrosis involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-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 referenced.Conclusions: it was reported that the patient underwent a medical procedure to address functional loss and arthrofibrosis of the knee.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.Catalog numbers and lot codes of other devices listed in this report: (b)(6), tritanium bplate triathlon s4, lot ctd58977.(b)(6), triathlon p/a ps beaded #5l, lot l7n7d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It has been reported "the sae happened on (b)(6) 2022.This patient had functional loss due to arthrofibrosis 8 weeks postoperatively.At (b)(6) 2022 the patient was hospitalized to perform manipulation under anesthesia.No explant or revision surgeries were done or planned.The event is related to the procedure (total knee arthroplasty), but we cannot say yet whether this is also related to this specific implant.".

• 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: 13859413
• Report Number: 0002249697-2022-00428
• Device Sequence Number: 16371365
• Product Code: MBH
• UDI-Device Identifier: 07613327338355
• UDI-Public: 07613327338355
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 01/31/2026
• Device Model Number: 5532-G-409-E
• Device Catalogue Number: 5532-G-409-E
• Device Lot Number: 3866AK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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: 59 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG