MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +3MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK

Model Number 5001-0303N-S

Device Problem Disassembly (1168)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.However, acumed employee attended the explanation surgery and was able to examine the parts at that time (before they were given to the patient).The laser lines between the head and the neck were aligned.There was no obvious damage to the articulating surface of the head.There is some damage noted on the stem but this may have been due to the removal of the stem from the canal.Additional mdr's associated with this event: 3025141-2017-00111: stem; 3025141-2017-00113: head.

Event Description

The head/neck portion of the anatomic radial head slide loc prosthesis dissociated from the stem post operatively.The implants were explanted.

• Brand Name: ARH SLIDE-LOC¿ NECK +3MM
• 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: 6600575
• MDR Text Key: 76261172
• Report Number: 3025141-2017-00112
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/29/2022
• Device Model Number: 5001-0303N-S
• Device Catalogue Number: 5001-0303N-S
• Device Lot Number: 364343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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