MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC HEAD 28MM, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0228L-S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The returned parts were inspected.The laser lines between the head and the neck were aligned properly (the two parts are still engaged.There was some shearing of material in the locking regions of the neck and stem.The dimensions that help define the locking regions on the stem and neck met specification.Additional mdrs associated with this event: 3025141-2017-0213: neck, 3025141-2017-0214: stem.

Event Description

An arh slide-loc radial head replacement product was implanted.At some point post op, the head/neck assembly dissociated from the stem.The implants were removed.

• Brand Name: ARH SLIDE-LOC HEAD 28MM, LEFT
• 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: 6909756
• MDR Text Key: 87982041
• Report Number: 3025141-2017-00212
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2023
• Device Model Number: 5001-0228L-S
• Device Catalogue Number: 5001-0228L-S
• Device Lot Number: 379593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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