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

Device Problem Fitting Problem (2183)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00163: neck, 3025141-2017-00164: stem.

Event Description

Arh slide-loc radial head replacement surgery was performed on (b)(6) 2016.Because of limit range of motion for the patient following the initial surgery, the surgeon decided that additional surgery was required.At that time, the head/neck assembly did not appear to be dissociated.During the second surgery, it was determined that the head/neck was not locked onto the stem, although it was still seated in place.The neck was replaced with a shorter one to address the range of motion issue and the other slide-loc implants (head and stem) were reused and filled locked into place.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
• 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 ; 8886279957
• MDR Report Key: 6718487
• MDR Text Key: 80202767
• Report Number: 3025141-2017-00162
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 98