MAUDE Adverse Event Report: ACUMED LLC 6.0MM X 0.0MM STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number TR-S0600-S

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00226: head 1, 3025141-2020-00227: stem 2, 3025141-2020-00228: head 2.

Event Description

While implanting an arh radial head replacement system in the patient, the initial stem was found to be loose in the bone canal so the stem was upsized however the head could not be removed from the stem so a new head was used.That stem was found to be too large so it was removed and a long stem was used, along with another new head.These actions caused a one hour long delay in surgery.

Manufacturer Narrative

H3: the returned radial head and stem were visually inspected under magnification for any defects.According to the information given, the returned head and stem (batch information is covered by the radial head) were loose in the patient.When the surgeon tried to switch sizes they found that the head and stem were secured tightly.This is an intended function of the device.When the implant is assembled it is not designed to come apart.Additional mdrs associated with this event: 3025141-2020-00226 follow up 1: head 1, 3025141-2020-00227: stem 2, and 3025141-2020-00228: head 2.

• Brand Name: 6.0MM X 0.0MM STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• MDR Report Key: 10542955
• MDR Text Key: 208324967
• Report Number: 3025141-2020-00225
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TR-S0600-S
• Device Catalogue Number: TR-S0600-S
• Device Lot Number: 412018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR