MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; TOURNIQUET, PNEUMATIC

Catalog Number UNK_INS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 02/23/2022

Event Type  Injury  

Event Description

Per the surgeon a smart pump device used during a knee replacement procedure may have resulted in damage to the patient¿s lymphatic system.During a follow up exam swelling was found in the knee area where the surgery was performed.The patient was given iv antibiotics & scanned to check for any venous obstructions; all scans were clear.Additional information has been requested from the user facility.

Event Description

Per the surgeon, a smart pump device used during a knee replacement procedure may have resulted in damage to the patient¿s lymphatic system.During a follow up exam, swelling was found in the knee area where the surgery was performed.The patient was given iv antibiotics and scanned to check for any venous obstructions.All scans were clear.No additional information was provided by the user facility.

• Brand Name: NA
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13697911
• MDR Text Key: 286839395
• Report Number: 3015967359-2022-00461
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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