MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71339548
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered an acetabular shell dislocation.The event was resolved with revision surgery.Cup has been destroyed and is not available for investigation.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 48MM
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7664710
• Report Number: 1020279-2018-01267
• Device Sequence Number: 2514870
• Product Code: MBL
• UDI-Device Identifier: 03596010598790
• UDI-Public: 03596010598790
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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 Model Number: 71339548
• Device Catalogue Number: 71339548
• Device Lot Number: 17EM07752
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 46 KG