MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-409

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)

Event Date 09/11/2013

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been another event for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Information received in follow-up includes a report dated september 11, 2013: "her main concern today is the effusion that has been behind her right knee.She notes that it is moderately painful.20 cc of serosanguineous fluid were drained from the knee.".

Manufacturer Narrative

Reported event: an event regarding patient factors is reported involving triathlon insert.The event of aspiration was confirmed based on medical review, but no device specific failure modes were identified or confirmed.Method & results: product evaluation and results- product inspection - material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinical review: a review of the provided medical records and/or x-rays by a clinical consultant stated that : the following adverse events were identified: revision due to patellar impingement and failure of fixation and subsequent quadriceps rupture with repair x2.The aspirations from the cross-referenced events were also confirmed.Hazards: none clearly related to implant conclusion of assessment: the revision surgery was confirmed as were the two quadriceps repairs.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been 01 other similar events for the lot referenced.Conclusions: the event was reported about patient factors is reported involving triathlon insert.The event of aspiration was confirmed based on medical review, but no device specific failure modes were identified or confirmed.A review of the provided medical records and/or x-rays by a clinical consultant stated that : ¿ the following adverse events were identified: revision due to patellar impingement and failure of fixation and subsequent quadriceps rupture with repair x2.The aspirations from the cross-referenced events were also confirmed.Hazards: none clearly related to implant conclusion of assessment: the revision surgery was confirmed as were the two quadriceps repairs.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.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 Description

Information received in follow-up includes a report dated (b)(6) 2013: "her main concern today is the effusion that has been behind her right knee.She notes that it is moderately painful.20cc of serosanguineous fluid were drained from the knee.".

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10167530
• MDR Text Key: 195555006
• Report Number: 0002249697-2020-01229
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: 07613327045802
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 5531-G-409
• Device Catalogue Number: 5531G409
• Device Lot Number: LCP991
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104