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

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

Patient Problem Pain (1994)

Event Type  Injury  

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.

Event Description

(report 7 of 8) in the article " radial head replacement for acute complex elbow instability: a long-term comparative cohort study of two implant designs" by sanchez, b.D.; et al, the authors performed a study to compare the long-term clinical and radiological 3 outcomes of two radial head replacement (rhr) designs in the context of complex 4 acute elbow instability.Ninety-five patients with an average age of 54 years (range, 21- 12 87 years) underwent an acute radial head replacement (rhr) (46 press-fit acumed anatomic radial head and 49 loose-fit 13 evolve metallic spacer) and were prospectively followed for an average of 61 months 14 (range, 24 to 157 months).Eight patients with an anatomic rhr (3 with overstuffing, 1 for stiffness, 2 with loose implants, and 2 with proximal forearm pain) and 1 patient with a spacer (with stiffness) required implant removal- the spacer was from a different manufacturer.This report is related to report numbers 3025141-2023-00443, 3025141-2023-00444, 3025141-2023-00445, 3025141-2023-00446, 3025141-2023-00447, 3025141-2023-00448 and 3025141-2023-00450.

• 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: 17798679
• MDR Text Key: 324036688
• Report Number: 3025141-2023-00449
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 08/28/2023
• 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