MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE LOC HEAD 22MM, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0222L-S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The returned head was examined under the microscope.The morse taper connection between the head and neck was secure.There was deformation around the bottom edge of the engagement surface.Additional mdrs associated with this event: 3025141-2017-00085: neck, 3025141-2017-00086: stem.

Event Description

The head/neck assembly of the arh slide-loc radial head implant separated from the stem post operatively.The head/neck assembly was explanted.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00085 follow up 1: neck, 3025141-2017-00086 follow up 1: stem.

Event Description

An arh slide-loc radial head system was implanted on an unknown date.On (b)(6) 2017, the implants were replaced due to loosening of the stem in the radial canal.New implants were used.(an mdr was previously filed for this event.).Three months later, the head/neck was found to be dissociated from the stem as shown in x-rays.The head/neck was replaced (the stem was left in place) in a second revision surgery on (b)(6) 2017.Four months post op the revision surgery, the head/neck had again dissociated, as seen on x-ray.A third revision surgery was performed (on (b)(6) 2017), where the arh slide-loc implants were replaced with an arh solutions radial head replacement system.

• Brand Name: ARH SLIDE LOC HEAD 22MM, LEFT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124-9432 ; 8886279957
• MDR Report Key: 6536500
• MDR Text Key: 74164541
• Report Number: 3025141-2017-00084
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/14/2023
• Device Model Number: 5001-0222L-S
• Device Catalogue Number: 5001-0222L-S
• Device Lot Number: 379586
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR