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

Catalog Number A502B000101

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Tears (2516)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the patient stated that she only wore the device for two days.The patient's skin was fragile, and the device was ripping open her skin.The patient was told by pt to stop using the device.No additional patient consequences were reported.

Event Description

It was reported that the patient stated that she only wore the device for 2 days, the patient's skin was fragile and the device was ripping open her skin.The patient was told by pt to stop using the device.It was unclear if there were contributing conditions "fragile skin or her legs were too swollen" that contributed to the event.No medical intervention was required.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4: udi#: (b)(4).Dhr and repair history review: the device history record (dhr) for activecare+sft unit serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.No additional action needed rationale: based on the complaint history review, there is no need for additional action; above noted complaints represent well understood events that have previously been subject to a comprehensive, documented complaint investigation.This complaint is determined not to be a new confirmed quality or manufacturing issue.Device evaluations results/investigation findings: as product was not returned, a device evaluation could not be performed.Probable cause/root cause: as product was not returned a probable cause could not be determined.Based on the information provided, this investigation determined that there is no need for further action at this time, as this complaint is determined to not be a new confirmed quality or manufacturing issue.This complaint will be tracked and trended for any adverse trends that may require additional actions.

• Brand Name: ACTIVECARE +SFT SYSTEM WARNING:
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9530276
• MDR Text Key: 173252075
• Report Number: 0001526350-2019-01202
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• PMA/PMN Number: K151377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: A502B000101
• Device Lot Number: 63985102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR