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  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records could not be reviewed as batch/lot number is unknown.A recall had been initiated for this device in 2017: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=154986.

Event Description

A possible broken or dislocated slide-loc device was reported.Per information received, the device was implanted 6 years ago (exact implant date unknown).The patient heard a "pop" (event date unknown) and presented to the clinic on (b)(6) 2022.Scheduling of a revision procedure was pending.Attempts to obtain further information regarding the patient, revision procedure date, and device information were made to no avail.This report is for the slide-loc neck and is related to report numbers 3025141-2022-00150 and 3025141-2022-00152 for the head and stem respectively.

Manufacturer Narrative

The devices were explanted (date of explant unknown) and returned for evaluation.The returned products were examined under magnification.A batch/lot number and part number were not visible in the slide-loc head/neck assembly and therefore, no batch number could be confirmed for the returned components.The slide-loc head/neck assembly showed signs of wear or deformation in two locations.First, around the hole on the side of the head where the slide-loc assembly tool engages.This hole showed some slight wear and dents around the edges.Second, the locking interface on the underside of the neck showed some slight curvature that appeared to indicate material was sheared off or deformed.A possible reason for slide-loc head/neck to disassemble from the stem include incorrect or inadequate attachment of the head/neck to the stem during implantation; however, the stem used with the head/neck was not returned.Therefore, no definitive conclusion can be made.

• 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: 14465206
• MDR Text Key: 292469738
• Report Number: 3025141-2022-00151
• 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,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• 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 Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: 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