MAUDE Adverse Event Report: SMITH AND NEPHEW 1. REFLECTION SHELL SZ D 48MM OD 2.REFLECTION LINER SZ E 28MM O DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 1. CAT: 71330450 3. 71336520

Device Problems Defective Device (2588); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 04/14/2021

Event Type  Injury  

Event Description

This letter is to inform you of this adverse event as the suspect device smith and nephew acetabular components: catalog: 71330048, -lot: n/a, description: reflection shell sz d 48mm od; catalog: 71330450, lot: 90300128, description: reflection liner sz e 28mm o deg; catalog: 71336520, lot: 80202672, description: 20mm length 6.5mm diameter uni is not manufactured or imported by depuy synthes joint reconstruction.Event description: clinical adverse event received for osteolysis : liner failure -wear.Event is definitely related to device and there is a remote possibility that it is related to procedure original implant date (b)(6) 2000.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1. REFLECTION SHELL SZ D 48MM OD 2.REFLECTION LINER SZ E 28MM O DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 17530850
• MDR Text Key: 321057126
• Report Number: MW5137766
• Device Sequence Number: 1
• Product Code: JDI
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1. CAT: 71330450 3. 71336520
• Device Lot Number: 1. 90300128
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1