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

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The head/neck assembly was returned (the stem was not returned).A visual inspection of the assembly showed that the laser lines were aligned properly.A visual examination of the neck showed some shearing of the leading edge of the surface that interfaces with the stem.On the opposite side of the neck, there was some deformation of the flange.An x-ray that showed the parts before they disassociated was reviewed and it appears that the head/neck assembly may not have been fully rotated which would cause the assembly to not be fully locked onto the stem.Associated mdrs for this event: 3025141-2016-00210: head, 3025141-2016-00211: neck.

Event Description

After implanting arh slide-loc radial head implants, the head/neck assembly partially disassociated from the stem.The head and neck were explanted; the stem remains implanted (with replacement head and neck implants).

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 6077494
• MDR Text Key: 59118362
• Report Number: 3025141-2016-00212
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• 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