MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530G711

Device Problems Degraded (1153); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Synovitis (2094); Injury (2348)

Event Date 09/26/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The patient was experiencing pain/poly synovitis.

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was confirmed.Method and results: device evaluation and results: the bearing surface shows abrasion, pitting and delamination which are commonly identified damage modes in uhmwpe inserts.The posterior/medial aspect of the bearing surface shows material deformation and fracture of the insert and delamination, indicative of posterior edge loading by the femoral component.Material loss on the posterior end of the insert progressed to the point where the baseplate became exposed, allowing for the direct contact of the femoral component and the baseplate.Multiple embedded metallic particles, most likely wear particles from the damaged baseplate were seen in the bearing surface, primarily in the posterior/medial region of the insert.Post-fracture delamination damage was observed posteriorly and explantation related damage anteriorly.Medical records received and evaluation: it would appear that an adverse mix of patient-related and procedure-related factors has contributed to overload and instability in the arthroplasty requiring revision.What exactly has caused failure in this case, the balance between patient-related and procedure-related factors cannot be substantiated in this case due to lack of good quality imaging information.Initial liner thickness was 11-mm cr type, which is about average for a typical knee replacement but because no pre-arthroplasty or early post arthroplasty x-rays are available for comparison, this aspect cannot be further detailed.Anatomic markers for proper reconstruction such as posterior femoral condylar offset or posterior tibial slope appear adequate on the available x-ray as far as visible but many relevant details may remain obscure due to the poor x-ray quality.Device history review: the device was 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: material analysis concluded that the damage to the insert was consistent with posterior edge-loading by the femoral component.Delamination on the posterior end of the insert progressed to the point where the baseplate became exposed, allowing for the direct contact of the femoral component and the baseplate.Medical review of the poor quality x-rays provided indicated revision surgery due to instability however the exact cause of the event could not be determined because insufficient information was provided.Further information such as better quality 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 was experiencing pain/poly synovitis.

• Brand Name: X3 TRIATHLON INSERT CR#7 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5262673
• MDR Text Key: 32578447
• Report Number: 0002249697-2015-04115
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 5530G711
• Device Lot Number: LBU883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 172