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

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

Patient Problem Arthritis (1723)

Event Type  Injury  

Event Description

In the article " does an internal joint stabilizer and standardized protocol prevent recurrent instability in complex persistent elbow instability?" by ma, c.H.Et al., the authors wanted to address the following questions: (1) does treatment of complex persistent elbow instability with a hinged internal joint stabilizer and a standardized protocol prevent recurrent instability and other complications? (2) what are the pre- to postoperative improvements in pain, disability, elbow performance, and rom? (3) is the development of post-traumatic arthritis associated with worse pain, disability, elbow performance, and rom? the study was conducted at an academic tertiary referral center from september 2014 to october 2019.The authors retrospectively analyzed patients with persistent dislocation or subluxation after initial treatment of traumatic elbow fracture dislocations.During the study, four patients underwent radial head replacement in the index surgery because of unsalvageable radial heads.Anatomic radial head arthroplasty (anatomic radial head system, acumed) was used in one patient, whereas loose stem radial head arthroplasty (different manufacturer) was used in the remaining three patients.The patient developed post-traumatic arthritis.

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 model number and batch/lot number 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, OR 97124
• MDR Report Key: 17374265
• MDR Text Key: 319673976
• Report Number: 3025141-2023-00365
• 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: 07/20/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/21/2023
• 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