MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER/BIOMET PALACES R+G 1X40; BONE CEMENT, ANTIBIOTIC

Device Problem Output Problem (3005)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling/ Edema (4577)

Event Date 12/23/2021

Event Type  Injury  

Event Description

After 4 weeks she developed exanthema in the surgical and scar area which has not regressed.The shoulder is always overheated, swollen, sensitive to touch, and ultrasound shows fluid in the shoulder.A tissue sample was taken by the dermatologist and results will be received on (b)(6) 2021 the orthopedist suspects an allergy to the metal used in the implant.Original implant date on (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ZIMMER/BIOMET PALACES R+G 1X40
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17528183
• MDR Text Key: 321139905
• Report Number: MW5135114
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1