MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC HEAD 22MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0222R-S

Device Problem Disassembly (1168)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The returned components were examined with the naked eye and under magnification.The head and neck remained assembled for this examination.Physical examination showed that the laser marks between the head and neck were aligned but the opposite end of the neck did not appear to be parallel with the slot on the head.There was damage in the locking regions of the neck but it is unclear if the locking region on the stem engaged the neck.There was damage on the stem platform but it is unclear when this damage occurred, during implantation or explantation.The components were also inspected to see if they continued to meet specifications.All of the measureable features were within specification.Some features were not measureable because the head/neck was still assembled and/or because of the damage of unknown origin.Additional mdrs associated with this event: 3025141-2017-00196: neck, 3025141-2017-00197: stem.

Event Description

An arh slide-loc radial head product was implanted.At some point post op, the head/neck assembly dissociated from the stem.The implants were explanted.

• Brand Name: ARH SLIDE-LOC HEAD 22MM, RIGHT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
• 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: 6833588
• MDR Text Key: 84085826
• Report Number: 3025141-2017-00195
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/07/2023
• Device Model Number: 5001-0222R-S
• Device Catalogue Number: 5001-0222R-S
• Device Lot Number: 379587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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: 38 YR