MAUDE Adverse Event Report: SMITH AND NEPHEW RICHARDS REFLECTION; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

The patient was revised due to superior poly wear on competitor liner.Replaced head and liner.Original implant date (b)(6) 1998.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RICHARDS REFLECTION
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 17528253
• MDR Text Key: 321284454
• Report Number: MW5135184
• Device Sequence Number: 1
• Product Code: KWY
• 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: 12/07/2020

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