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

Catalog Number 5530-G-311

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had a triathlon knee (b)(6) 2010 and when reviewed in (b)(6) 2015 complained of pain.Patient underwent revision left knee surgery and the 11mm cr insert was removed and replaced with a 16 mm cs insert.

Manufacturer Narrative

Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection of the returned device noted wear impression markings on the distal surface of the insert, consistent with contact against the baseplate.Explantation damage was observed on the anterior surface of the insert.Damage was also observed on the posterior surface of the insert.Delamination, burnishing, scratching, third-body indentations and embedded debris was also observed on the condyles.A material analysis was conducted on the received devices and the report concluded "delamination, burnishing, scratching, pitting and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.Wear impression markings, explantation damages and embedded debris were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: a material analysis was conducted on the received devices and the report concluded "delamination, burnishing, scratching, pitting and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.Wear impression markings, explantation damages and embedded debris were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined." the event was confirmed but the root cause could not be determined.No further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

Patient had a triathlon knee (b)(6) 2010 and when reviewed in (b)(6) 2015 complained of pain.Patient underwent revision left knee surgery and the 11mm cr insert was removed and replaced with a 16mm cs insert.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6118603
• MDR Text Key: 60580402
• Report Number: 0002249697-2016-03745
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 5530-G-311
• Device Lot Number: MHL3X6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 72