MAUDE Adverse Event Report: ACUMED, LLC ARH SLIDE-LOC¿ STANDARD STEM 9MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number 5001-0109N-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The returned products were visually inspected under magnification to confirm failure.The neck was still attached to the radial head but the stem was removed completely.The laser marking for aligning the neck to the head was aligned.The underside of the neck was slightly damaged with some slight discoloration, most likely occurring during insertion.There was a metal piece that was broken off and lodged in between the neck and the head.It was not possible to confirm what the piece belonged to, and it could not be removed without disassembling the parts.The top of the stem was not in good condition.All edges looked to be damaged, scratched, or bent in some way.Since the stem was disassembled from its original insertion, it could not be confirmed if the locking feature engaged.If the head clamp was misaligned, there could be a false indication that the head/neck is fully inserted.No definitive conclusion could be made as to what caused the failure.A recall had been initiated for this device in 2017: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=154986.

Event Description

It was reported that the patient had reported pain and loss of motion (date unknown).It was determined the arh slide loc head had dislodged from the stem.The original implant was acumed's radial head slide-lock implanted on (b)(6) 2016.Failure of the implant was initially determined by fluoroscopy (date unknown) and confirmed during revision surgery on (b)(6) 2022.The head of the implant had broken free from the stem.The original device including head and stem were removed and an arh solutions 2 head and stem were then implanted.Revision surgery completed on (b)(6) 2022 with no issues.This report is related to report numbers 3025141-2022-00112 and 3025141-2022-00113 for the other devices involved in this event.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 9MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14190182
• MDR Text Key: 289907305
• Report Number: 3025141-2022-00111
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5001-0109N-S
• Device Catalogue Number: 5001-0109N-S
• Device Lot Number: 380689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3025141-2017-0003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other