MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problem Unstable (1667)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 08/03/2012

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

As reported: "event included in the reported submitted as proof of milestone for an investigation initiated study (b)(6).Per the report received 3/31/2020, indication for revision is pain and instability; femoral component and tibial liner revised.".

Manufacturer Narrative

Reported event: an event regarding instability & dislocation involving a triathlon femoral component was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as product was not returned.Clinical review: a review of the provided medical records by a clinical consultant stated that: [.] when examining the knee, the joint was unstable and had recurvatum.The patellar bone was deficient with only 6 mm left.The procedure did not appear to have any complications and was performed in a routine fashion however, it required additional time due to the patient's high bmi of 43.While details of her hospital course were not provided the medical consultation confirmed her multiple medical problems, a stable podtoperative exam and confirmed that the intraoperative cultures were negative.[.] hazards: none clearly related to implant [.] conclusion of assessment: the mechanisms of failure and causes of revision [.] appeared dynamic and unrelated to the implants.This was a very complicated case in a patient with multiple comorbid conditions.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a clinician review of the provided medical records states the following: hazards none clearly related to implant [.] the mechanisms of failure and causes of revision [.] appeared dynamic and unrelated to the implants.This was a very complicated case in a patient with multiple comorbid conditions.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned,.

Event Description

As reported: "event included in the reported submitted as proof of milestone for an investigation initiated study (b)(6).Per the report received 3/31/2020, indication for revision is pain and instability; femoral component and tibial liner revised.".

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• 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: 10006435
• MDR Text Key: 189358022
• Report Number: 0002249697-2020-00818
• Device Sequence Number: 1
• Product Code: MBH
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 5510F501
• Device Lot Number: SJEKP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 107