MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 11MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0111N-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The head, neck, and stem was already assembled together when received.The components were separated to obtain the part and batch numbers.The laser marks between the head and neck were aligned.There were some marks/damage on the neck flange and stem platform.The unlocking torque was calculated to be less than the required (as manufactured) specification.The diameter of the stem measured to be within manufacturing specifications.Additional mdrs associated with this event: 3025141-2018-00115: head.3025141-2018-00116: neck.

Event Description

An arh slide-loc radial head replacement system was explanted on (b)(6) 2018 for unknown reasons.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 11MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7314410
• MDR Text Key: 101562074
• Report Number: 3025141-2018-00117
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: 5001-0111N-S
• Device Catalogue Number: 5001-0111N-S
• Device Lot Number: 359467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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