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

Model Number 5001-0222L-S

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The explanted parts were examined.The parts were returned assembled.The laser lines on the head, neck and stem were aligned properly.There was no gross damage to the parts, although there was some marks of unknown origin on the side of the head and on the neck/stem interface.The stem, including the grit blast area, showed no damage.The diameter of the stem was measured and was found to be in specification.Additional mdrs associated with this event: 3025141-2017-00130: stem; 3025141-2017-00131: neck.

Event Description

Following implantation of an arh slide-loc radial head prosthesis, the stem loosened in the bone.Implants were explanted.There was no issue with the implant - the head neck was in the 'locked' position.

• Brand Name: ARH SLIDE-LOC¿ HEAD 22MM, LEFT
• 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
• MDR Report Key: 6657555
• MDR Text Key: 78088206
• Report Number: 3025141-2017-00132
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/13/2023
• Device Model Number: 5001-0222L-S
• Device Catalogue Number: 5001-0222L-S
• Device Lot Number: 377186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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: 63 YR