MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +1MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK

Model Number 5001-0301N-S

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The returned components were visually examined.The laser lines of the implants were properly aligned.There was some damage to the interface surfaces of the neck and the stem.There were burnish marks on the faces of the neck and stem.Additional mdrs associated with this event: 3025141-2017-00173: stem, 3025141-2017-00174: head.

Event Description

Arh slide-loc radial head replacement implants were implanted on (b)(6) 2017.At some point post operatively, the head/neck assembly dissociated from the stem.The implants were explanted on (b)(6) 2017.

• Brand Name: ARH SLIDE-LOC¿ NECK +1MM
• 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 ; 8886279957
• MDR Report Key: 6718564
• MDR Text Key: 80203735
• Report Number: 3025141-2017-00172
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/28/2023
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Device Lot Number: 399047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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: 76 YR
• Patient Weight: 65