MAUDE Adverse Event Report: ACUMED, LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as model number and batch/lot number are unknown.The device was not returned for evaluation.Based on the information received, the root cause could not be determined.

Event Description

In the article " stress shielding around press-fit radial head arthroplasty: proposal for a new classification system based on the analysis of 97 patients with a mid-term follow-up and a review of the literature" by giannicola, g., et al, the authors report stress shielding (ss) around press-fit radial head arthroplasty (rha) has been reported as a cause of a new type of proximal radial neck resorption (prnr).The authors stated very few studies have analyzed this phenomenon, and no comprehensive classification is currently available.The authors thus decided to clinically and radiographically analyze 97 patients who underwent a press-fit rha and who were followed up for a mean period of 72 months (range: 2-14 years).Prnr in the four quadrants of the radial neck was assessed.The authors designed a novel ss classification based on (1) the degree of resorption of the length of the radial neck and (2) the number of neck quadrants involved on the axial plane.The mean prnr (mprnr) was calculated as the mean resorption in the four quadrants.Mprnr was classified as mild (3 mm), moderate (3 to 6 mm), and severe (6 mm).The authors conducted a retrospective comparative study on 144 consecutive patients (67 males and 77 females), with a mean age of 54 years (18 to 87), who underwent rha performed by a single elbow surgeon between january 2008 and december 2019.The inclusion criteria were: (1) patients with anatomical or bipolar radial head arthroplasty consisting of conical or cylindrical short press-fit stems (anatomical radial head system, acumed, hillsboro, or, usa; or a device from another manufacturer); (2) a surgical procedure performed for unreconstructible fractures or post-traumatic sequelae of the radial head (symptomatic non-union or malunion); (3) primary rha; and (4) adult patients (18 years).Proximal radial neck resorption was reported in an unknown number of patients as the data was commingled with the implanted devices from another manufacturer.The proximal radial neck resorption was stated to not have caused any further patient complications.

• 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 rd.; hillsboro, OR 97124
• MDR Report Key: 18895766
• MDR Text Key: 337569836
• Report Number: 3025141-2024-00265
• 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: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other