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-411

Device Problems Material Discolored (1170); Material Distortion (2977); Naturally Worn (2988); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Insert change due to poly wear.

Manufacturer Narrative

Returned to manufacturer on.An event regarding wear involving an insert was reported.The event was confirmed.Visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2017.It states "the parts were examined with the aid of a stereo microscope at magnifications up to 50x.Explantation damage was observed on the insert.Areas with no machining lines were observed on the distal surface of the insert.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmpwe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid." a material analysis has been performed.The report concluded: "burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmpwe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a principal contributor to the present knee instability was the relatively high posterior tibial slope of the baseplate with an angle of 8°.Under normal implantation conditions, this should never be more than 5°, usually between 0° - 5°.Dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review confirmed that there have been no other similar events for the reported lot.A review of the provided medical records and x-rays by a clinical consultant indicated: baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange.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

Insert change due to poly wear.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6999311
• MDR Text Key: 90968236
• Report Number: 0002249697-2017-03196
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MMRDP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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: 70 YR
• Patient Weight: 81