MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71339550
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to right hip recurring dislocation.Procedure: revision right total hip arthroplasty of acetabular component and femoral head.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6541033
• Report Number: 1020279-2017-00314
• Device Sequence Number: 16370173
• Product Code: MBL
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71339550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017; 07/23/2024
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 10/03/2017; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL HEAD PART#71343200 LOT#UNKNOWN; SCREW PART# 71332525 LOT# UNKNOWN; SHELL PART# 71335550 LOT# UNKNOWN; STEM PART# 71356006 LOT# UNKNOWN; FEMORAL HEAD PART#71343200 LOT#UNKNOWN; SCREW PART# 71332525 LOT# UNKNOWN; SHELL PART# 71335550 LOT# UNKNOWN; STEM PART# 71356006 LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female