MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-709
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	09/26/2018
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 events for the lot referenced.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 #6l; 5517f601 ; clj4b.Tritanium bplate triathlon s7; 5536b700 ; ctd16205.Tritanium patella-asymmetric; 5552-l-381; dpn0.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
In providing records for a revision of the patient's left knee on (b)(6) 2019, an office visit note from (b)(6) 2018 indicates patient complaint of pain and recurring swelling.An aspiration "of 30 cc of blood tinged fluid" was performed.Study site confirmed that no further information will be released.
Event or Problem Description
In providing records for a revision of the patient's left knee on (b)(6) 2019, an office visit note from (b)(6) 2018 indicates patient complaint of pain and recurring swelling.An aspiration "of 30 cc of blood tinged fluid" was performed.Study site confirmed that no further information will be released.
Additional Manufacturer Narrative
Reported event an event regarding patient factors involving a triathlon insert was reported.The event was confirmed through 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 information by a clinical consultant indicated: adverse event identified: pain and multiple aspirations after primary uncemented mako tka.Revision tka for instability and swelling.Aspiration and swelling post-operatively after revision tka.Ongoing pain after tka revision.Hazards: the pcl laxity and aspirations were not a hazard relative to the implants.There may have been loosening/failure to in-grow of the uncemented femoral component.Conclusion of assessment: the patient had an uncemented tka cruciate retaining with mako.Multiple swelling episodes and aspirations occurred postoperatively.The knee was felt unstable and underwent revision.The stability of the femoral implant was not described.The revision improved the knee instability.An aspiration was required early in the post-operative period from the revision.The knee stability was improved but the patient continued to have pain and some dissatisfaction with the knee.Other than the potential failure to in-grow on the femur the issues did not appear to be implant related.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been 3 other similar events for the reported lot, for the same patient/device.Conclusions: the medical review concluded the patient had an uncemented tka cruciate retaining with mako.Multiple swelling episodes and aspirations occurred postoperatively.The knee was felt unstable and underwent revision.The stability of the femoral implant was not described.The revision improved the knee instability.An aspiration was required early in the post-operative period from the revision.The knee stability was improved but the patient continued to have pain and some dissatisfaction with the knee.Other than the potential failure to in-grow on the femur the issues did not appear to be implant related.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.

• Brand Name: X3 TRIATHLON CS INSERT #7 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11192928
• Report Number: 0002249697-2021-00142
• Device Sequence Number: 18993206
• Product Code: MBH
• UDI-Device Identifier: 07613327046007
• UDI-Public: 07613327046007
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 05/31/2022
• Device Model Number: 5531-G-709
• Device Catalogue Number: 5531G709
• Device Lot Number: LFX363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 84