MAUDE Adverse Event Report: ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD AND STEM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Bone Shedding Debris (4557)

Event Type  malfunction  

Event Description

An arh radial head replacement system was implanted into the patient.Post operatively, the patient experienced implant loosening and bone loss, due to stress shielding of the implant.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD AND STEM
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 12096498
• MDR Text Key: 261912040
• Report Number: 3025141-2021-00063
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• 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