MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G613

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems Arthritis (1723); Rheumatoid Arthritis (1724); Pain (1994); Injury (2348)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The patient underwent initial tka surgery on (b)(6) 2016.The patient's underlying disease was rheumatoid arthritis.One year after the primary surgery, the patient complained of pain of the treated knee, and the revision surgery, which was exchanged only the cs insert, was performed on (b)(6) 2017.

Manufacturer Narrative

Additional information: device evaluated by mfg; corrected information: catalog #.An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: a material analysis has been performed.The report concluded: damages consistent with the explantation process were observed on the insert.The tibial insert was observed to have burnishing, scratching, pitting, and third body indentations.These are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the insert.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: procedure-related factors: - cs component choice in probably pcl dysfunctional knee patient-related factors, - rheumatoid arthritis of the knee with soft tissue destruction., device-related factors: - none as also supported by the mar findings., diagnosis: - cr/cs component choice in a probably pcl dysfunctional knee due to rheumatoid arthritis knee disease has contributed to early instability requiring revision with bearing exchange.The patient¿s obesity quite likely played a secondary role to increase the overload condition.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: a clinical consultant indicated: the indication for revision surgery was provided by the surgeon as pain while liner exchange would indicate that the problem was related to instability, consistent with a diagnosis of rheumatoid arthritis where soft tissue destruction including the knee ligaments is a prominent characteristic of the disease.Although patient-related factors regarding the underlying disease of rheumatoid arthritis quite likely played a prominent role to contribute to instability, procedure-related factors regarding suboptimal component position may also play a role.Whatever the cause of the problem, this may remain an educated guess due to lack of more clinical information, but root cause is related to surgical technique and choice of optimal component size during primary arthroplasty and as such is in principal procedure-related while magnified by patient-related factors associated with prior joint disease, certainly applicable to this patient with rheumatoid arthritis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as further x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient underwent initial tka surgery on (b)(6) 2016.The patient's underlying disease was rheumatoid arthritis.One year after the primary surgery, the patient complained of pain of the treated knee, and the revision surgery, which was exchanged only the cs insert, was performed on (b)(6) 2017.

• Brand Name: X3 TRIATHLON CS INSERT #6 13MM
• 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: 7102616
• MDR Text Key: 94344064
• Report Number: 0002249697-2017-03528
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2019
• Device Catalogue Number: 5531G613
• Device Lot Number: LDY511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 128