MAUDE Adverse Event Report: ZIMMER SURGICAL INC. MCS ACTIVECARE +SFT SYSTEM; COMPRESSIBLE LIMB SLEEVE

Model Number A502B-0001-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Edema (2020); Thrombosis (2100)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

Device was tested and no mechanical failure was found.Manufacturer was unable to test device with the adapter and the sleeves used by the patient because they were not returned with the device.

Event Description

Patient had surgery for total replacement of right hip on (b)(6) 2018.She began wearing the active care + sft on (b)(6) 2018 and she was discharged to her home and used a walker to get around.While wearing the device, patient experienced pain, swelling ankles and calf tightness and could not walk.She saw her surgeon for her two week checkup.After she was examined he admitted her to the hospital.They found that she had a dvt in her right knee, and multiple clots in both legs which went into her heart and lungs.Patient was placed on a heparin drip and prescribed xarelto (she is still on xarelto).

• Brand Name: MCS ACTIVECARE +SFT SYSTEM
• Type of Device: COMPRESSIBLE LIMB SLEEVE
• Manufacturer (Section D): ZIMMER SURGICAL INC.; 200 west ohio ave; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL INC.; 200 west ohio ave; dover OH 44622
• Manufacturer Contact: ralph buster ; 200 west ohio ave; dover, OH 44622
• MDR Report Key: 8095802
• MDR Text Key: 128080017
• Report Number: 9616558-2018-00002
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: A502B-0001-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR