MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DCON P-FIT STEM COCR15MMX155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	6478-6-440
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/01/2021
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.
Event or Problem Description
Patient stated he had a left knee surgery on (b)(6) 2020 (apprx) with stryker implants and was revised on (b)(6) 2021 due to cracked implant.Patient stated this is his 7th left knee surgery but is unsure if previous ones are stryker implants.Patient stated that he is now experiencing his knee cap going to the side when he walks which makes him want to trip.Patient is not sure if his 2021 implants are stryker implants.This report is for his 2021 revision due to cracked implant.
Event or Problem Description
Patient stated he had a left knee surgery on (b)(6) 2020 (apprx) with stryker implants and was revised on (b)(6) 2021 due to cracked implant.Patient stated this is his 7th left knee surgery but is unsure if previous ones are stryker implants.Patient stated that he is now experiencing his knee cap going to the side when he walks which makes him want to trip.Patient is not sure if his 2021 implants are stryker implants.This report is for his 2021 revision due to cracked implant.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a duracon stem was reported.The event was confirmed via medical review.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 the provided medical information by a clinical consultant indicated: "a review of medical records with a clinical consultant indicated "i can confirm that this event took place since i was able to review the operation reports and one lateral xray 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." -device history review: review of the product history records indicate the devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusion: it was reported patient was revised due to disassociation of the femoral component from the stem.A review of medical records with a clinical consultant indicated "i can confirm that this event took place since i was able to review the operation reports and one lateral xray 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 is possible at this time.Should more information become available the complaint will be reopened.

• Brand Name: DCON P-FIT STEM COCR15MMX155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14390529
• Report Number: 0002249697-2022-00692
• Device Sequence Number: 6528044
• Product Code: JWH
• UDI-Device Identifier: 07613327044782
• UDI-Public: 07613327044782
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2022

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: 06/30/2021
• Device Model Number: 6478-6-440
• Device Catalogue Number: 64786440
• Device Lot Number: A2T4Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 112 KG