MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS CVD FEM ST W/O BODY 13X127; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-813
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
This report is for the revision in (b)(6) 2020 for broken stem, due to fall.Hmrs was used on (b)(6) 2001.Since the stem broke due to patient fall in (b)(6) 2020, it was replaced on (b)(6) 2020.On (b)(6) 2020, revision surgery was done due to infection.Patient fell again, and x-ray showed that the clip had come off.

• Brand Name: MRS CVD FEM ST W/O BODY 13X127
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11512686
• Report Number: 0002249697-2021-00485
• Device Sequence Number: 3844477
• Product Code: KRO
• UDI-Device Identifier: 07613327048605
• UDI-Public: 07613327048605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 03/31/2025
• Device Model Number: 6485-3-813
• Device Catalogue Number: 64853813
• Device Lot Number: 226370A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/18/2021
• 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