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

Model Number 5001-0303N-S

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional mdr's associated with this event: mdr 3025141-2016-00129: head; mdr 3025141-2016-00130: stem.

Event Description

A slide-loc anatomic radial head was implanted on (b)(6) 2016.At a follow up appointment (approximately four month after implantation), x-rays showed that the head/neck assembly had partially disassociated from the stem some time post-operatively.Revision surgery has not been scheduled.

Manufacturer Narrative

The returned head, neck and stem parts were examined.The parts were received with the head and neck assembled.The laser lines on the head and the neck were aligned properly.The locking interface region on the neck and the stem was damaged.Damage to the interface was most likely caused by the stem clamp not being fully seated on the stem prior to rotation.Additional mdrs associated with this event: mdr 3025141-2016-00129: head follow up 1.Mdr 3025141-2016-00130: stem follow up 1.

Event Description

Revision surgery was performed (b)(6) 2016.

• 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 ; 5036279957
• MDR Report Key: 5679749
• MDR Text Key: 46014308
• Report Number: 3025141-2016-00128
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: 5001-0303N-S
• Device Catalogue Number: 5001-0303N-S
• Device Lot Number: 327820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• 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