MAUDE Adverse Event Report: OSSUR HF ICEROSS TRANSFEMORAL LOCKING; LINER

Catalog Number I-713230

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

User lost suspension when liner slipped of residual limb during use due to excessive perspiration.User fell resulting in a broken wrist requiring surgery.

Manufacturer Narrative

User lost suspension when liner slipped off the residual limb during use due to excessive perspiration.User fell resulting in a broken wrist requiring surgery.Product was not returned for evaluation but description from customer states that there is no evidence of any faults with the liner.User was working outside in very hot weather when the incident occurred.Excessive perspiration likely caused the biomechanics of the liner-skin interface to change, influencing the prosthetic attachment of the stump.Hygiene problems such as perspiration are common when using a silicone liner, but these problems can be controlled by daily washing of the stump and liner.Dimensional changes can alter the fit of the prosthesis throughout the day, while sweating can cause the biomechanics of the liner-skin interface to change which might influence the prosthetic attachment of the residual limb.User has been wearing this liner type and size since 2019 and cpo confirms that liner size and fit are good for the user.To assist the user, knee sleeve was provided and antiperspirant advise was given.Caution that excessive perspiration can compromise the suspension are in the instructions for use.Further actions are not considered warranted.

• Brand Name: ICEROSS TRANSFEMORAL LOCKING
• Type of Device: LINER
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 12675015
• MDR Text Key: 282844485
• Report Number: 3003764610-2021-00004
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: I-713230
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention