MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +1MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK

Model Number 5001-0301N-S

Device Problem Disassembly (1168)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The explanted implants were examined.The head and neck were aligned properly.There as damage in the locking regions of the neck and stem, which can be created when the neck is not fully seated on the stem and locking is attempted.Additional mdrs associated with this event: 3025141-2017-00154: stem, 3025141-2017-00155: head.

Event Description

An arh slide-loc radial head was implanted on (b)(6) 2017.At some point postop, the head/neck assembly dissociated from the stem.On (b)(6) 2017, the implants were explanted.

• Brand Name: ARH SLIDE-LOC¿ NECK +1MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK
• 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
• MDR Report Key: 6680036
• MDR Text Key: 78772833
• Report Number: 3025141-2017-00156
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/14/2023
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Device Lot Number: 374838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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