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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

In the article " risk of radial head arthroplasty revision is correlated with radial head diameter: a multicenter analysis of 405 cases." by mirzayan, r., lowe, n., acevedo, dc., and singh, a, the authors wanted to determine the optimal implant type and radial head diameter for radial head arthroplasty (rha).A retrospective analysis of rha cases performed by 75 surgeons at 14 medical centers in an integrated health care system between 2006 and 2017 was completed.405 cases met inclusion criteria.It was stated acumed brand anatomic radial head implants in addition to competitor radial head implants were used.Device information for the acumed anatomic radial head is unknown.The study found that revision rate was positively correlated with increasing radial head diameter.A 26-mm head had 7.7 odds of revision compared to a size 18-mm head.More than 95% of revision cases were performed within the first 36 months of the index procedure.There was a significantly higher overall reoperation rate for terrible triad (18.4%) vs.Isolated injuries (10.4%) (p =.04).There was no difference between acumed anatomic and competitor radial head implants in overall reoperation, implant revision, postoperative range of motion, or patient-reported outcomes.It is unknown how many revisions occurred with those implanted with the acumed brand anatomic radial head implants.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Based on the information available, 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: 16996879
• MDR Text Key: 315913585
• Report Number: 3025141-2023-00316
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 05/08/2023
• 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