MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #1L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to instability.A triathlon 2x11 insert was revised to a thicker insert.Intra-operatively, the anterior lip of the liner appeared to be worn.The surgeon would like the liner investigated.Rep provided the primary operative report and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has minor damage in the form of scratches consistent with contact against explantation tooling.Remnants of bony ingrowth is present on the bone-interfacing surface of the device.There is nothing further remarkable to note.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the patient underwent a left triathlon total knee arthroplasty in 2015 and it failed in 2021 due to instability according to the narrative.I cannot confirm that the event occurred since i only have the original primary operation with no other corroboration except as noted in the narrative.Regarding the possible root cause of this event, i cannot determine this with certainty.Failure for instability is multi factorial including surgical technique and implantation, the patient¿s body habitus and activity level and ligament competency." -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: it was reported that the patient was revised due to instability.Visual inspection of the returned device indicated that the device has minor damage in the form of scratches consistent with contact against explantation tooling.Remnants of bony ingrowth is present on the bone-interfacing surface of the device.There is nothing further remarkable to note.A review of the provided medical information by a clinical consultant indicated: "the patient underwent a left triathlon total knee arthroplasty in 2015 and it failed in 2021 due to instability according to the narrative.I cannot confirm that the event occurred since i only have the original primary operation with no other corroboration except as noted in the narrative.Regarding the possible root cause of this event, i cannot determine this with certainty.Failure for instability is multi factorial including surgical technique and implantation, the patient¿s body habitus and activity level and ligament competency." 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
It was reported that the patient's left knee was revised due to instability.A triathlon 2x11 insert was revised to a thicker insert.Intra-operatively, the anterior lip of the liner appeared to be worn.The surgeon would like the liner investigated.Rep provided the primary operative report and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON P/A CR BEADED #1L
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12689890
• Report Number: 0002249697-2021-01756
• Device Sequence Number: 20080052
• Product Code: MBH
• UDI-Device Identifier: 07613327041606
• UDI-Public: 07613327041606
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 05/31/2016
• Device Model Number: 5517-F-101
• Device Catalogue Number: 5517F101
• Device Lot Number: S3XHF8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female