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: 3025141-2019-00153: case 1; 3025141-2019-00154: case 2; 3025141-2019-00156: case 4; 3025141-2019-00157: case 5; 3025141-2019-00158: case 6; 3025141-2019-00159: case 7.

Event Description

Article: radial head ingrowth anatomic implant versus smooth stem monoblock implant in acute terrible triad injury: a prospective comparative study.Rodriguez-quintana, david, comulada, david beaton, rodriguez-quintana, natalie, lopez-gonzalez, francisco.J orthop trauma; volume 31, number 9, septemeber 2017, 503-509.Case 3: ectopic bone formed post op.In a revision surgery, ectopic bone removed and capsular release performed.Heterotopic ossification developed.

• 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: 8448675
• MDR Text Key: 139725033
• Report Number: 3025141-2019-00155
• 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: 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
• Is this a Product Problem Report?: No
• 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