MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 64MM; PROST, HIP, SEMI-CNSTRND, MET/CER/CER/MET, CMNTD OR UNCMNTD

Model Number	71335564
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/1990
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a revision surgery performed due to dislocation, patient hip is close to 2 inches higher on the right leg and has bursitis in his hip.The new orthopedic surgeon stated that another surgery has to be performed in order to fix the length discrepancy or live with the pain.

• Brand Name: R3 3 HOLE ACET SHELL 64MM
• Common Device Name: PROST, HIP, SEMI-CNSTRND, MET/CER/CER/MET, CMNTD OR UNCMNTD
• 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 ; 0447940038246
• MDR Report Key: 9927445
• Report Number: 1020279-2020-01156
• Device Sequence Number: 2817693
• Product Code: MRA
• UDI-Device Identifier: 03596010598301
• UDI-Public: 03596010598301
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2023
• 2 Devices were Involved in the Event: 1 2

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: 71335564
• Device Catalogue Number: 71335564
• Device Lot Number: 10DM17345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/03/2021; 03/22/2022; 05/26/2023
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/10/2021; 03/24/2022; 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2010
• 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: 71338708 / LOT 10 AM10507.; 7134264 /16AW07587.; 71930704 / 04GM19954.
• Patient Sex: Unknown