MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

(b)(6) first report of retrievals for statement of work 10 for july 1, 2023 and ending on december 1, 2023.A depuy synthes implant was revised and reviewed for analysis reason for revision: ""loose pain ".This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REDAPT STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 18970726
• MDR Text Key: 338585030
• Report Number: MW5153118
• Device Sequence Number: 1
• Product Code: MEH
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1