MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +5MM; PROSTHESIS, ELBOW, NECK

Model Number 5001-0305N-S

Device Problems Material Separation (1562); Failure to Align (2522)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: mdr 3025141-2016-00136 head.Mdr 3025141-2016-00138 stem.

Event Description

Arh slide-loc product was implanted on (b)(6) 2016.On (b)(6) 2016, during a routine follow up examination, it was discovered that the head/neck assembly had disassociated from the stem.The implants were explanted on (b)(6) 2016.The sales rep reports that the laser lines on the head and neck were not aligned after rotation to lock; this leads to incomplete locking of the implants.

• Brand Name: ARH SLIDE-LOC¿ NECK +5MM
• Type of Device: PROSTHESIS, ELBOW, 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: 5757106
• MDR Text Key: 48402982
• Report Number: 3025141-2016-00137
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• 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: 5001-0305N-S
• Device Catalogue Number: 5001-0305N-S
• Device Lot Number: 364291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• 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