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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2019-00168: case 1.

Event Description

Article: clinical and radiographic comparisions of two different radial head implant designs.Berschback, john.C, lynch t.Sean, kalainov, david m., wysocki, robert w., merk, bradley r., cohen, mark s.J shoulder elbow surg (2013) 22, 1108-1120.Case 2: heterotopic ossification (class iib) formed post op.Revision surgery was performed to excise ho, release contracture, and remove hardware.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL
• 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 ; 8886279957
• MDR Report Key: 8448532
• MDR Text Key: 139732412
• Report Number: 3025141-2019-00169
• Device Sequence Number: 0
• Product Code: KWI
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• 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): Required Intervention