MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLONASYMCONEAUGSZ E LM/RL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5549-A-251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208); Muscle/Tendon Damage (4532)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
This pi is to cover the revision that occurred on (b)(6) 2023 due to patella tendon rupture.Patient noted that they had to go back and reattach soft tissue on his patella, also replaced scr synthetic shaft, hinge pin femur, and hinge lps.Patient left voice mail on patient voice line indicating possible breakage of stryker implant.Patient noted implantation on (b)(6) 2023.Additional info: implant failure.Physician stated a failed junction causing the femur stem to rotate and dislocate and he has to push it back and it should not.Had a knee infection which resulted in him having initial knee implants.Also has competitor implants.
Additional Manufacturer Narrative
An event regarding patient factors (patella tendon rupture) involving a triathlon augment was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had reimplantation of a prosthesis after infection on (b)(6) 2023 since i was able to review the operation report.I am also able to confirm that the patient underwent a patellar tendon reconstruction on december 18, 2023 since i was also able to review the operation report.It is unclear to me what the "event" reported for a stryker product is.Root cause analysis: this patient had multiple surgeries for infection, had a spacer inserted, and then a reconstruction using a competitor implant with stryker cement and a stryker tibial cone.There is no mention of any problem related to stryker cement or the stryker cone implant.In the second procedure the surgeon elected to remove the competitor axle and poly for exposure and then performed a patella tendon reconstruction with capsular repair.There was no mention in the operation report itself about the use of cement although under the materials used, they did state one pack of cement was "implanted" it is unclear where that would be.The root causes of infection following total knee arthroplasty are multifactorial including surgical technique, possible wound contamination, possible wound healing problems and possible seeding of the joint from a remote source.Causes of patella tendon rupture are also multifactorial including surgical technique, with possible partial disruption of the tendon at surgery, degeneration of the tendon, and weaking due to infection and multiple surgeries.These have nothing to do with the stryker products used and i would not assign any causality to them." 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 required repair of a ruptured patella tendon and revision of competitor products.No allegations were reported against the stryker augment or cement.A full investigation is completed on this device to document the review of information received; however, there was no evidence that the subject devices contributed to the event, and they were not reported to be revised.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had reimplantation of a prosthesis after infection on (b)(6) 2023 since i was able to review the operation report.I am also able to confirm that the patient underwent a patellar tendon reconstruction on december 18, 2023 since i was also able to review the operation report.It is unclear to me what the "event" reported for a stryker product is.Root cause analysis: this patient had multiple surgeries for infection, had a spacer inserted, and then a reconstruction using a competitor implant with stryker cement and a stryker tibial cone.There is no mention of any problem related to stryker cement or the stryker cone implant.In the second procedure the surgeon elected to remove the competitor axle and poly for exposure and then performed a patella tendon reconstruction with capsular repair.There was no mention in the operation report itself about the use of cement although under the materials used, they did state one pack of cement was "implanted" it is unclear where that would be.The root causes of infection following total knee arthroplasty are multifactorial including surgical technique, possible wound contamination, possible wound healing problems and possible seeding of the joint from a remote source.Causes of patella tendon rupture are also multifactorial including surgical technique, with possible partial disruption of the tendon at surgery, degeneration of the tendon, and weaking due to infection and multiple surgeries.These have nothing to do with the stryker products used and i would not assign any causality to them." furthermore, the use of stryker devices in combination with those of another manufacturer is considered off-label.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
This pi is to cover the revision that occurred on (b)(6) 2023 due to patella tendon rupture.Patient noted that they had to go back and reattach soft tissue on his patella, also replaced scr synthetic shaft, hinge pin femur, and hinge lps.Patient left voice mail on patient voice line indicating possible breakage of stryker implant.Patient noted implantation on (b)(6) 2023.Additional info: implant failure.Physician stated a failed junction causing the femur stem to rotate and dislocate and he has to push it back and it should not.Had a knee infection which resulted in him having initial knee implants.Also has competitor implants.Additional info: i had a ct scan done with this finding: external rotation of the distal femoral component relative to the femoral neck, 46.2 degrees.

• Brand Name: TRIATHLONASYMCONEAUGSZ E LM/RL
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19706664
• Report Number: 0002249697-2024-00979
• Device Sequence Number: 7479902
• Product Code: MBH
• UDI-Device Identifier: 07613327000733
• UDI-Public: 07613327000733
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 02/29/2024
• Device Catalogue Number: 5549-A-251
• Device Lot Number: HMA4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White