MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #2 PS BOX CUTTING GUIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6541-5-712

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional information has been requested and if received will be provided in a supplemental report.Not returned.

Event Description

It was reported by the surgeon that a condylar fracture had occurred at some point during the total knee procedure.It was reported that the origin of the fracture is unclear.The fracture was reported to be fixed intra-operatively with 2 cancellous screws and a fiber-wire suture.It was reported that the additional time required for this complication was 20min.

• Brand Name: #2 PS BOX CUTTING GUIDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7596625
• MDR Text Key: 110907992
• Report Number: 0002249697-2018-01795
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327242812
• UDI-Public: 07613327242812
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6541-5-712
• Device Lot Number: AL2E12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention