MAUDE Adverse Event Report: ACUMED LLC 8MM MORSE TAPER LONG STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM

Model Number TR-SL08-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Additional mdr associated with this event: 3025141-2020-00194; head.

Event Description

An arh radial head replacement system was implanted in the patient on (b)(6) 2019.Post op, the patient developed an infection that moved throughout the body so the hardware was removed.The doctor does not believe the hardware was the root cause of the reaction.

• Brand Name: 8MM MORSE TAPER LONG STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or ; 6279957138
• MDR Report Key: 10425663
• MDR Text Key: 203502701
• Report Number: 3025141-2020-00193
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TR-SL08-S
• Device Catalogue Number: TR-SL08-S
• Device Lot Number: 454085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2018
• 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