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

Model Number	5530-G-411
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Instability and poly wear.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event.An event regarding instability involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results.-product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i had the opportunity to review the additional information including the product inquiry summary, an operative report , implant record, x-ray report and an office note.The event description from the product inquiry summary states: instability and poly wear i can glean from these reports is that the patient had a cemented triathalon knee.X-rays revealed poly wear medially and that this knee was revised.It is confirmed that the patient had a revision surgery related to tibial insert polyethylene insert wear.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review the additional information including the product inquiry summary, an operative report , implant record, x-ray report and an office note.The event description from the product inquiry summary states: instability and poly wear i can glean from these reports is that the patient had a cemented triathalon knee.X-rays revealed poly wear medially and that this knee was revised.It is confirmed that the patient had a revision surgery related to tibial insert polyethylene insert wear.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Instability and poly wear.
Event or Problem Description
Instability and poly wear.
Additional Manufacturer Narrative
Reported event: an event regarding inst:ability and wear involving a triathlon insert was reported.The wear event was confirmed through clinician review of the provided medical records and evaluation of the returned device.Instability was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.-clinician review: a review of the provided medical records by a clinical consultant stated the following: "i have had the opportunity to review the additional information related to including the product inquiry summary, an operative report , implant record, x-ray report and an office note.The event description from the product inquiry summary states: instability and poly wear what i can glean from these reports is that the patient had a cemented triathalon knee.X-rays revealed poly wear medially and that this knee was revised.It is confirmed that the patient had a revision surgery related to tibial insert polyethylene insert wear.The root cause of this issue cannot be established by the limited documentation provided." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient was revised due to instability and wear.Visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant stated the following: "i have had the opportunity to review the additional information related to including the product inquiry summary, an operative report , implant record, x-ray report and an office note.The event description from the product inquiry summary states: instability and poly wear.What i can glean from these reports is that the patient had a cemented triathalon knee.X-rays revealed poly wear medially and that this knee was revised.It is confirmed that the patient had a revision surgery related to tibial insert polyethylene insert wear.The root cause of this issue cannot be established by the limited documentation provided." no further investigation for this event is possible 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13692047
• Report Number: 0002249697-2022-00346
• Device Sequence Number: 5009604
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

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: 08/31/2015
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MJLP81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 11/29/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/20/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 74 KG