MAUDE Adverse Event Report: ASCENSION ORTHOPEDIC INC ASCENSION MODULAR RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Lot Number 09-0131 MRH-350-24S-WW 10-02

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Myalgia (2238); Swelling/ Edema (4577)

Event Description

Pain swelling soreness stiffness.

• Brand Name: ASCENSION MODULAR RADIAL HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ASCENSION ORTHOPEDIC INC
• MDR Report Key: 15699551
• MDR Text Key: 302814039
• Report Number: MW5112980
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 09-0131 MRH-350-24S-WW 10-02
• Patient Sequence Number: 1
• Treatment: 01 STEM