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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported "progressive pain and swelling over last year.Elevated cell count and appearance of infection, but poly wear much more aggressive wear than would expect".
Event or Problem Description
As reported "progressive pain and swelling over last year.Elevated cell count and appearance of infection, but poly wear much more aggressive wear than would expect".
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event of infection was not confirmed, however wear was confirmed based on material analysis of the returned device.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 19 march 2019 which indicated: damage was observed on the insert condyles, consistent with contact against the femoral component.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Delamination, burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.The material analysis report concluded: damage was observed on the femoral component and baseplate, consistent with contact against each other.Delamination, burnishing, scratches and third-body indentations were observed on the tibial insert condyles.Additionally, burnishing, scratching and third body indentations were observed on the patella insert.These are common damage modes of uhmwpe.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray confirms a subluxated femoral component.Need operative reports, clinical/office notes, histopathology reports, and serial x-rays.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusion: visual inspection was performed as part of the material analysis report (mar), dated 19 march 2019 which indicated: damage was observed on the insert condyles, consistent with contact against the femoral component.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Delamination, burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.The material analysis report concluded: damage was observed on the femoral component and baseplate, consistent with contact against each other.Delamination, burnishing, scratches and third-body indentations were observed on the tibial insert condyles.Additionally, burnishing, scratching and third body indentations were observed on the patella insert.These are common damage modes of uhmwpe.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The event of infection was not confirmed and root cause of infection or the wear observed could not be determined based on the information provided.Further information such as serial x-rays, operative reports, clinical/office notes as well as histopathology are required to complete the investigation for confirming the infection and determining a root cause for both issues identified.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8367651
• Report Number: 0002249697-2019-01179
• Device Sequence Number: 19232367
• Product Code: MBH
• UDI-Device Identifier: 07613327050448
• UDI-Public: 07613327050448
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 5530-G-311
• Device Lot Number: 8XJMKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR