MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DCON P-FIT STEM COCR13MMX155MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64786438
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
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.H3 other text: device not returned.
Event or Problem Description
Patient reported that allegedly his tibial stem cracked and requires revision surgery.The patient has not been revised.(left knee).
Event or Problem Description
Patient reported that allegedly his tibial stem cracked and requires revision surgery.The patient has not been revised.(left knee).
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a duracon stem 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 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." i patient complains of pain and instability following at least surgeries with five revisions of his left knee.His last surgery has resulted in recurrent dislocation of the patella.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 are failure due to breakage of an implant is multifactorial including surgical technique factors, surgical technique, 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.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.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: 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.I patient complains of pain and instability following at least surgeries with five revisions of his left knee.His last surgery has resulted in recurrent dislocation of the patella.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 are failure due to breakage of an implant is multifactorial including surgical technique factors, surgical technique, 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.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 additional information become available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Executive summary updated based on med review.Reported event an event regarding crack/fracture involving a duracon stem 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 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." addendum dated 18 oct 2023: 'conclusion of assessment: based upon the new pi generated, my previous assessment in my addendum of may 28, 2022, is unchanged.I patient complains of pain and instability following at least surgeries with five revisions of his left knee.His last surgery has resulted in recurrent dislocation of the patella.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 are failure due to breakage of an implant is multifactorial including surgical technique factors, surgical technique, 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.' addendum dated december 10 2023: my previous assessment in my first addendum of october 18, 2023, is unchanged.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.-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: 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."addendum dated 18 oct 2023: 'conclusion of assessment: based upon the new pi generated, my previous assessment in my addendum of may 28, 2022, is unchanged.I patient complains of pain and instability following at least surgeries with five revisions of his left knee.His last surgery has resulted in recurrent dislocation of the patella.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 are failure due to breakage of an implant is multifactorial including surgical technique factors, surgical technique, 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.' addendum dated december 10 2023: my previous assessment in my first addendum of may 28, 2022, is unchanged.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 additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported that allegedly his tibial stem cracked and requires revision surgery.The patient has not been revised.(left knee).Update 01/12/24: per med review "the last surgery on (b)(6), 2023, was a revision of all components using a competitor implant.".

• Brand Name: DCON P-FIT STEM COCR13MMX155MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17587512
• Report Number: 0002249697-2023-00911
• Device Sequence Number: 2544591
• Product Code: KRO
• UDI-Device Identifier: 07613327044775
• UDI-Public: 07613327044775
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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: 09/30/2020
• Device Catalogue Number: 64786438
• Device Lot Number: AMF6D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 12/16/2023; 01/16/2024
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2015
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 112 KG