MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 12MM; PROSTHESIS, ELBOW, STEM

Model Number 5001-0112N-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The returned parts were examined both with the naked eye and under magnification.The laser marks on the head and neck were slightly misaligned by 2.1°.The leading corner of the locking feature on the neck was sheared away, indicating that the stem clamp was not completely seated on the stem when the head/neck assembly was rotated to lock.This misalignment can provide a false indication that the head/neck assembly was fully seated and locked on the stem.Rotating prior to fully seating of the stem clamp on the stem can shear the corner on the neck.Additional mdr's associated with this event: mdr 3025141-2016-00142, head; mdr 3025141-2016-00143, neck.

Event Description

Arh slide-loc products were implanted on (b)(6) 2016.At some point post operatively, the head/neck assembly disassociated from the stem.The parts were explanted on (b)(6) 2016.

Manufacturer Narrative

Incorrect lot number initially reported.All information presented in this mdr is information for the correct lot number.Additional mdrs associated with this event: 3025141-2016-00142 follow up 1: head; 3025141-2016-00143 follow up 1: stem.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 12MM
• Type of Device: PROSTHESIS, ELBOW, STEM
• 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 ; 5036279957
• MDR Report Key: 5760435
• MDR Text Key: 48502807
• Report Number: 3025141-2016-00144
• 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,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/13/2023
• Device Model Number: 5001-0112N-S
• Device Catalogue Number: 5001-0112N-S
• Device Lot Number: 372595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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
• Patient Age: 24 YR
• Patient Weight: 100