MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #4 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5531-G-410-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar event for the lot referenced for the same patient.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.The following devices were also listed in this report: triathlon p/a cr beaded #3l; cat# 5517f301; lot# lt64s, tritanium patella-asymmetric; cat# 5552-l-320; lot# pptn1.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 reported primary left tka in (b)(6) 2021 and has reported "tremendous" pain since.Patient had a manipulation in (b)(6) 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.This report is for manipulation under anesthesia.
Additional Manufacturer Narrative
Reported event: an event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pis ,including the 2 product inquiry summary, stating the same complaint.An operative report from the index surgery and implant record from (b)(6) 2021and an operative report from a manipulation under anesthesia performed on (b)(6) 2021.The event description from the product inquiries summary states: pi this pi is for manipulation under anesthesia.Patient reported primary left tka in october 2021 and has reported "tremendous" pain since.Patient had a manipulation in december 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.Pi this pi is for pain after manipulation.Patient reported primary left tka in (b)(6) 2021 and has reported "tremendous" pain since.Patient had a manipulation in (b)(6) 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.The patient underwent a primary total knee arthroplasty on (b)(6) 2021 and manipulation under anesthesia on (b)(6) 2021.Post manipulation the patient had 120 degrees of flexion.Arthrofibrosis requiring manipulation under anesthesia is confirmed.The root cause for the arthrofibrosis cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.-device history review: review of the device history records indicate the 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.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pis ,including the 2 product inquiry summary, stating the same complaint.An operative report from the index surgery and implant record from (b)(6) 2021 and an operative report from a manipulation under anesthesia performed on (b)(6) 2021.The event description from the product inquiries summary states: pi this pi is for manipulation under anesthesia.Patient reported primary left tka in october 2021 and has reported "tremendous" pain since.Patient had a manipulation in december 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.This pi is for pain after manipulation.Patient reported primary left tka in (b)(6) 2021 and has reported "tremendous" pain since.Patient had a manipulation in (b)(6) 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.The patient underwent a primary total knee arthroplasty on 10/14/21 and manipulation under anesthesia on (b)(6) 2021.Post manipulation the patient had 120 degrees of flexion.Arthrofibrosis requiring manipulation under anesthesia is confirmed.The root cause for the arthrofibrosis cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.It is noted that the patient is inquiring if the reported device is subject to a product recall.Based on the product details provided the reported device is not subject to product recall.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported primary left tka in (b)(6) 2021 and has reported "tremendous" pain since.Patient had a manipulation in (b)(6) 2021 and has reported continuous pain.Patient would like to know if implants are subject to a recall.This report is for manipulation under anesthesia.

• Brand Name: X3 TRIATHLON INSERT CS #4 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15342531
• Report Number: 0002249697-2022-01291
• Device Sequence Number: 5037985
• Product Code: JWH
• UDI-Device Identifier: 07613327390452
• UDI-Public: 07613327390452
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 03/31/2025
• Device Model Number: 5531-G-410-E
• Device Catalogue Number: 5531-G-410-E
• Device Lot Number: MP0AR6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 98 KG