MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 CR INSERT 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530P316

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

Patient Problems Swelling (2091); Injury (2348); No Code Available (3191)

Event Date 11/18/2015

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

Triathlon knee was revised.Pitting noted on removed insert.

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was confirmed.Method and results: device evaluation and results: material analysis concluded; symmetrical wear, discoloration, burnishing, scratching, third body indentations and pitting were present on the triathlon insert.Discoloration is attributed to the absorption of synovial fluid.Burnishing, scratching, third body indentations and pitting are common failure modes of uhmwpe during in vivo use.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: not performed as medical records were not provided.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 burnishing, scratching, third body indentations and pitting noted on the insert are common failure modes of uhmwpe during in vivo use.No material or manufacturing defects were observed on the surfaces examined.Further information such as pre- and post-operative x-rays, operative reports as well as patient details and 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

Triathlon knee was revised.Pitting noted on removed insert.

• Brand Name: TRIATHLON #3 CR INSERT 16MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5312308
• MDR Text Key: 33925177
• Report Number: 0002249697-2015-04318
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Catalogue Number: 5530P316
• Device Lot Number: LM707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2004
• 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