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

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

Patient Problem Ankylosis (4527)

Event Type  Injury  

Event Description

(report 2 of 2).In the article " therapeutic effect of resection, prosthetic replacement and open reduction and internal fixation for the treatment of mason type iii radial head fracture." by chen, h.W., tian, j.L., and zhang, y.Z., the authors performed a prospective, non-randomized, parallel-controlled study to compare the therapeutic effects and identify the most effective treatment method for mason type iii radial head fracture.They assessed patients with mason type iii radial head fracture treated with resection, prosthetic replacement, and orif to compare preoperative and postoperative pain condition, elbow joint function, curative effect, and complication rate.Acumed anatomic humeral head prosthesis.For this study that used the acumed anatomic humeral head prosthesis, it was reported one patient had heterotopic ossification and one patient had ankylosis.This report is related to report number 3025141-2023-00346.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information received, the root cause could not be determined.

• 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 97124
• MDR Report Key: 17262032
• MDR Text Key: 318578720
• Report Number: 3025141-2023-00347
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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