MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B500
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Patient called stating she had a left knee replacement about a year ago.Few months after implantation she started experiencing loosening and difficulty walking.Patient was revised to competitive devices on (b)(6) 2018.Patient is seeking compensation.
Additional Manufacturer Narrative
Correction: no explant date, device remains implanted.An event regarding alleged loosening & difficulty walking involving a triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned as they remain implanted.Medical records received and evaluation: review of medical records by a consulting clinician revealed: "on (b)(6) 2017 a primary left total knee arthroplasty was performed for a pre- and post-operative diagnosis of ¿left knee arthritis and deformity¿.No primary.Operative report of the right total knee stated to be performed in (b)(6) 2015 or listing of the primary components removed at revision surgery to competitive products on (b)(6) 2018 is available.There is no documentation of any clinical problems with the left stryker total knee arthroplasty implanted on (b)(6) 2017, which was not revised.There are no x-rays available for review or examination of explanted right total knee arthroplasty components to determine if they were stryker.In this morbidly obese chronic pain patient dependent on narcotics, no documented complaints referable to the stryker primary total knee arthroplasty performed on (b)(6) 2017 in the left knee are noted.The event description appears to onfuse the left total knee arthroplasty with the right revision surgery." product history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: it was reported that allegedly the patient experienced loosening and difficulty walking.The medical review noted: "there is no documentation of any clinical problems with the left stryker total knee arthroplasty implanted on (b)(6) 2017, which was not revised." the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation as they remain implanted and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Patient called stating she had a left knee replacement about a year ago.Few months after implantation she started experiencing loosening and difficulty walking.Patient was revised to competitive devices on (b)(6) 2018.Patient is seeking compensation.Update per medical review: patient had a right knee revision on (b)(6) 2018 (competitor devices), not a left knee revision.This pi to cover "loosening & difficulty walking" without revision.
Additional Manufacturer Narrative
Correction - (b)(6) 2024: as per the medical review, "there is no documentation of any clinical problems with the left stryker total knee arthroplasty implanted on (b)(6)2017, which was not revised.There are no x-rays available for review or examination of explanted right total knee arthroplasty components to determine if they were stryker." additionally, the patient corrected her statement to report problems with her right knee, not the left stryker knee.Therefore, there is no indication that this patient's experience is related to stryker devices and this complaint is being canceled.
Event or Problem Description
Update from patient: patient stated she had problems with her right knee not left knee.She stated she will send her medical records.Update from medical review: there is no documentation of any clinical problems with the left stryker total knee arthroplasty implanted on (b)(6) 2017, which was not revised.There are no x-rays available for review or examination of explanted right total knee arthroplasty components to determine if they were stryker.Patient called stating she had a left knee replacement about a year ago.Few months after implantation she started experiencing loosening and difficulty walking.Patient was revised to competitive devices on (b)(6) 2018.Patient is seeking compensation.Update per medical review: patient had a right knee revision on (b)(6) 2018 (competitor devices), not a left knee revision.This pi to cover "loosening & difficulty walking" without revision.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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 NJ NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7803652
• Report Number: 0002249697-2018-02626
• Device Sequence Number: 18904845
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2022
• Device Catalogue Number: 5520B500
• Device Lot Number: CAP2T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/29/2019; 01/25/2024
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 08/23/2019; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2017
• 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; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 118 KG