MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DCON P-FIT STEM COCR 15MMX80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786400
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a left knee surgery where stryker components were implanted on (b)(6) 2019.Patient was revised on (b)(6) 2020 for loosening.
Additional Manufacturer Narrative
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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
An event regarding loosening involving an unknown stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "this inquiry reports a patient complaining of pain and instability following at least 6 surgeries (5 revisions) on his left knee, the last resulting in recurrent dislocation of the patella.I can confirm that this event took place since i was able to review the operation reports and one lateral x ray showing the disassociation of the stem from the distal femoral component.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of failure due to breakage is multifactorial, including surgical technique factors including cementing technique, patient factors such as bmi and activity level and implant factors, including proper assembly." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's knee was revised due to loosening.A review of medical records with a clinical consultant indicated "this inquiry reports a patient complaining of pain and instability following at least 6 surgeries (5 revisions) on his left knee, the last resulting in recurrent dislocation of the patella.I can confirm that this event took place since i was able to review the operation reports and one lateral x ray showing the disassociation of the stem from the distal femoral component.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of failure due to breakage is multifactorial, including surgical technique factors including cementing technique, patient factors such as bmi and activity level and implant factors, including proper assembly."no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a left knee surgery where stryker components were implanted on (b)(6) 2019.Patient was revised on (b)(6) 2020 for loosening.
Event or Problem Description
Patient had a left knee surgery where stryker components were implanted on (b)(6), 2019.Patient was revised on (b)(6), 2020 for loosening.
Additional Manufacturer Narrative
An event regarding loosening involving a duracon stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the patient complained of pain and instability following at least 7 surgeries with 6 revisions of his left knee.His previous surgeries have resulted in loose and broken implants and recurrent dislocation of the patella.The last surgery on (b)(6), 2023, was a revision of all components using a competitor implant.We have no information about how the patient is doing at this time.I can confirm that these events occurred since i was able to review operation reports and one lateral x-ray showing the broken femoral stem.As i have said previously the root cause of these events cannot be determined with certainty.Causes of failure due to breakage of an implant and loosening are multifactorial including surgical technique factors, including alignment, ligament balance, restoration of kinematics, cementing technique, as well as patient factors such as activity level and bmi and implant factors including proper assembly and proper fixation of the implants.Regarding the possible fracture of a tibial stem, i cannot confirm that event." device 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 reported lot.Conclusion: it was reported that the patient was revised due to loosening of the femoral components.A review of the provided medical records by a clinical consultant indicated: "the patient complained of pain and instability following at least 7 surgeries with 6 revisions of his left knee.His previous surgeries have resulted in loose and broken implants and recurrent dislocation of the patella.The last surgery on (b)(6), 2023, was a revision of all components using a competitor implant.We have no information about how the patient is doing at this time.I can confirm that these events occurred since i was able to review operation reports and one lateral x-ray showing the broken femoral stem.As i have said previously the root cause of these events cannot be determined with certainty.Causes of failure due to breakage of an implant and loosening are multifactorial including surgical technique factors, including alignment, ligament balance, restoration of kinematics, cementing technique, as well as patient factors such as activity level and bmi and implant factors including proper assembly and proper fixation of the implants.Regarding the possible fracture of a tibial stem, i cannot confirm that event." 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.

• Brand Name: DCON P-FIT STEM COCR 15MMX80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14506554
• Report Number: 0002249697-2022-00765
• Device Sequence Number: 5539008
• Product Code: JWH
• UDI-Device Identifier: 07613327044669
• UDI-Public: 07613327044669
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K924482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2024
• 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: 07/31/2021
• Device Catalogue Number: 64786400
• Device Lot Number: BBY3N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 05/03/2024
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/16/2022; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2016
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 112 KG