MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 CR INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-P-609
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The following was reported: change of insert from 9 to 11 mm and addition of patella.After exchange of insert the surgeon observed backside wear on the insert.
Additional Manufacturer Narrative
Reported event: an event regarding instability and wear involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated the damage on the articulating surface of the insert is consistent with 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.No obvious wear was observed.Dimensional inspection: dimensional inspection was not performed because the event does not relate to device dimensions.Functional inspection: functional inspection was not performed because the event does not relate to device function.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Clinician review: a review of medical records with a clinical consultant indicated "conclusion/assessment: a patellar resurfacing was performed as part of a revision surgery for ongoing patellofemoral pain after a tka using an uncemented triathlon knee.Event confirmation: the event of a revision with patellar resurfacing and poly exchange can be confirmed.The assertion that there was backside wear cannot be confirmed.Root cause: the root cause of the revision was patellar pain form an unresurfaced patella.A root cause for the asserted backside wear cannot be ascertained as it cannot be confirmed." 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.Conclusions: the exact cause of the event could not be determined.Visual inspection of the returned device indicated the damage on the articulating surface of the insert is consistent with 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.No obvious wear was observed.A review of medical records with a clinical consultant indicated "conclusion/assessment: a patellar resurfacing was performed as part of a revision surgery for ongoing patellofemoral pain after a tka using an uncemented triathlon knee.Event confirmation: the event of a revision with patellar resurfacing and poly exchange can be confirmed.The assertion that there was backside wear cannot be confirmed.Root cause: the root cause of the revision was patellar pain form an unresurfaced patella.A root cause for the asserted backside wear cannot be ascertained as it cannot be confirmed."no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: change of insert from 9 to 11 mm and addition of patella.After exchange of insert the surgeon observed backside wear on the insert.

• Brand Name: TRIATHLON #6 CR INSERT 9MM
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16032497
• Report Number: 0002249697-2022-01882
• Device Sequence Number: 20701798
• Product Code: MBH
• UDI-Device Identifier: 07613327041873
• UDI-Public: 07613327041873
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2023

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: 11/30/2024
• Device Model Number: 5530-P-609
• Device Catalogue Number: 5530P609
• Device Lot Number: LJR172
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2019
• 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: 54 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG