MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/10/2019
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 have been no 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.
Event or Problem Description
Patient has had persistent pain and swelling in knee in the anterior aspect of the knee right after surgery and it never went away.X rays were done and there was possible wear on the undersurface of the patella.Patient was unsure about getting a revision done and wanted to continue with conservative measures.Knee was aspirated with showed negative for infection.Patella resurfacing and liner exchange was scheduled on (b)(6) 2019 for surgery on (b)(6) 2019.
Additional Manufacturer Narrative
An event regarding revision involving a triathlon insert was reported.The event was confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation:a review of the provided medical records by a clinical consultant stated the following comment: patient who received a knee arthroscopy without patellar resurfacing and polyethylene exchange.No device related factors were contributory to the event.The failure to resurface the patella with a preoperative finding of arthritis may have contributed to her initial complaints leading to the revision surgery.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device needed to complete the investigation for determining root cause.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.
Event or Problem Description
Patient has had persistent pain and swelling in knee in the anterior aspect of the knee right after surgery and it never went away.X rays were done and there was possible wear on the undersurface of the patella.Patient was unsure about getting a revision done and wanted to continue with conservative measures.Knee was aspirated with showed negative for infection.Patella resurfacing and liner exchange was scheduled on (b)(6) 2019 for surgery on (b)(6) 2019.

• Brand Name: X3 TRIATHLON CS INSERT #3 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: 9659086
• Report Number: 0002249697-2020-00206
• Device Sequence Number: 14288182
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 01/31/2024
• Device Model Number: 5531-G-309
• Device Catalogue Number: 5531G309
• Device Lot Number: LHX392
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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: 72 YR
• Patient Weight: 77