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

Model Number 5001-0305N-S

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2016-00253: head, 3025141-2016-00255: stem.

Event Description

After implanting arh slide-loc radial head implants, the head/neck assembly partially disassociated from the stem.Explant surgery is scheduled.

Manufacturer Narrative

The head and neck implants were attached with the morse taper engaged when the returned product was received.The laser lines between the two parts were aligned.The parts were then separated to perform the physical examination.The implant neck was examined visually.There was deformation of the flange of the neck in two locations almost directly opposite of each other.The deformations are located in the space that is occupied by the locking features of the implant stem.The flange at the entrance of the locking interface is missing (deformed or sheared away).No root cause of the damage can be identified.However, the complainant did note the patient fell immediately before the disassociation was discovered.Additional mdrs associated with this event: 3025141-2016-00253 follow up 1: head.3025141-2016-00255 follow up 1: stem.

Event Description

After implanting arh slide-loc radial head implants, the patient fell.When x-rays were taken following the fall, it was determined that the head/neck assembly was partially disassociated from the stem.The parts were explanted.

• Brand Name: ARH SLIDE-LOC¿ NECK +5MM
• Type of Device: NECK, PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 6175385
• MDR Text Key: 62748766
• Report Number: 3025141-2016-00254
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/29/2022
• Device Model Number: 5001-0305N-S
• Device Catalogue Number: 5001-0305N-S
• Device Lot Number: 364290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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