MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #6 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5620-B-601
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/04/2015
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "aseptic loosening, combined patellofemoral medial compartment arthroplasty, left knee.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a triathlon baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a partial knee replacement with patellar resurfacing since i was able to see the implants on the grid list.I can also confirm that at some point the patient had a total knee arthroplasty since i was able to view x-rays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a partial knee replacement with patella resurfacing are multifactorial.These include surgical technique in the way the partial knee implant is positioned and aligned, whether or not proper stability/laxity was obtained, whether or not the cruciate ligaments were competent, and cement technique.Patient factors, including lifestyle, activity level, and bmi also contribute.I would not assign any causality to the implants based upon the information provided." -device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a partial knee replacement with patellar resurfacing since i was able to see the implants on the grid list.I can also confirm that at some point the patient had a total knee arthroplasty since i was able to view x-rays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a partial knee replacement with patella resurfacing are multifactorial.These include surgical technique in the way the partial knee implant is positioned and aligned, whether or not proper stability/laxity was obtained, whether or not the cruciate ligaments were competent, and cement technique.Patient factors, including lifestyle, activity level, and bmi also contribute.I would not assign any causality to the implants based upon the information provided." if additional information and/or devices becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PKR BASEPLATE #6 LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8570370
• Report Number: 0002249697-2019-01822
• Device Sequence Number: 2346364
• Product Code: HRY
• UDI-Device Identifier: 07613327015591
• UDI-Public: 07613327015591
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 04/30/2015
• Device Catalogue Number: 5620-B-601
• Device Lot Number: ANUAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male