MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DCON P-FIT STEM COCR 16MMX80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786405
Medical Device Problem Codes	Break (1069); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Or manager at the clinic, reported the following event : "revision surgery of left knee prosthesis for femoral loosening.Observation of rupture of the femoral stem.Update 23 may 2018: fractured stem was returned with the femoral component - it is noted that the stem has fractured on the threaded section.Portion of threaded section remains inside femoral component.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a duracon stem was reported.The event was confirmed through material analysis.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated on (b)(6) 2018.In addition the stem and femoral component were returned for evaluation.There is bone cement and bony ingrowth visible on the internal fixation surface of the femoral component.The stem was fractured at the threads.Part of the stem remained inside the femoral component.The material analysis concluded: the stem fractured in fatigue.Eds showed the femoral component and the stem to be consistent with astm f1537.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.Medical records received and evaluation: not performed as no medical records were received for review.Product history review: indicated all 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.Conclusion: the material analysis reported concluded: the stem fractured in fatigue.Eds showed the femoral component and the stem to be consistent with astm f1537.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.The exact cause of the event could not be determined based on the information provided.Further information such as pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Operating room manager at the clinic, reported the following event : "revision surgery of left knee prosthesis for femoral loosening.Observation of rupture of the femoral stem.Update 23 may 2018: fractured stem was returned with the femoral component, it is noted that the stem has fractured on the threaded section.Portion of threaded section remains inside femoral component.

• Brand Name: DCON P-FIT STEM COCR 16MMX80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7540450
• Report Number: 0002249697-2018-01561
• Device Sequence Number: 16450233
• Product Code: JWH
• UDI-Device Identifier: 07613327044676
• UDI-Public: 07613327044676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 64786405
• Device Lot Number: ARS2P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention