MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 10MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0110N-S

Device Problems Break (1069); Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: a 3025141-2017-00229: head.A 3025141-2017-00230: neck.

Event Description

A patient was experiencing possible grinding/interference with the implanted arh slide-loc radial head replacement product.In a post op xray, the stem looks like it has loosened in the canal of the bone.Additionally, the neck appears to have been damaged and may have separated from the stem.Revision surgery has not been scheduled.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 10MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, 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 ; 8886279957
• MDR Report Key: 6905921
• MDR Text Key: 89465778
• Report Number: 3025141-2017-00228
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/04/2023
• Device Model Number: 5001-0110N-S
• Device Catalogue Number: 5001-0110N-S
• Device Lot Number: 381003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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