MAUDE Adverse Event Report: ACUMED, LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported the device had to be explanted on (b)(6) 2022 due to displaced/dislodged head on the stem.The initial implant procedure had occurred 7 years ago.No further information is available.This report is for the head of the device and is related to report number 3025141-2022-00138 for the neck and report number 3025141-2022-00139 for the stem.

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.The returned product was inspected under magnification.Under magnification the batch number of the arh slide-loc standard stem 7mm (part number 5001-0107n) was confirmed as 328328.The head and stem were disassembled upon return.The returned stem showed significant signs of scratching, denting, deformation and damage around the surface and canal that interact with the head.The shaft of the stem contained wear around the grit blast surface and biologic material was stuck to the underside of the top of the stem that appeared to resemble bone.The underside of the radial head component showed areas of scratches, denting and wear as well, with foreign material stuck in the center of the neck, on the side which mates with the stem.The top side of the radial head did not show any signs of wear or damage.It was not possible to know if the damage observed occurred during the assembly, implantation, or removal of the device.The surgical technique for the slide-loc system denotes: "caution: the head/neck assembly should be done on a firm surface (ie, avoid using a mayo stand) to ensure that adequate force is applied to the morse taper connection" as well as "warning: incomplete locking between the head and neck may result in disengagement of the components postoperatively".No definitive conclusion can be made regarding the reported event.A recall had been initiated for this device in 2017: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=(b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14347671
• MDR Text Key: 291310337
• Report Number: 3025141-2022-00137
• 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: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3025141-2017-0003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other