MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71352503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/21/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a dislocation of the right hip joint.The patient was treated in hospital from the (b)(6) 2011 to the (b)(6) 2011.Multiple closed reductions were done.Events were classified by aemb as sades and deemed to represent a single complaint considering they all relate to same total hip.
Additional Manufacturer Narrative
The associated smf stem with stiktite was not returned for evaluation.However, our investigation indicated that the related device was part of field action initiated in 2016.Corrective actions have been initiated.Our clinical evaluation noted that several attempts have been made to obtain clinical/medical documents to no avail. without supporting clinical/medical documents a thorough investigation cannot be performed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information become available this complaint can be re-assessed.

• Brand Name: SMF STEM WITH STIKTITE SZ 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 7534022
• Report Number: 1020279-2018-00997
• Device Sequence Number: 176102
• Product Code: LPH
• UDI-Device Identifier: 03596010619594
• UDI-Public: 03596010619594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/12/2023

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 Expiration Date: 06/12/2020
• Device Model Number: 71352503
• Device Catalogue Number: 71352503
• Device Lot Number: 09MTM0011G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 05/01/2018; 05/01/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/03/2018; 07/12/2023; 10/05/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• 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: 71331754, 75007448.; 71331854 R3 0 HOLE ACET SHELL 54MM.; 71352116 LEFT ANTEVERTED MODULAR NECK.; UNK FEMORAL HEAD.; 71331854 R3 0 HOLE ACET SHELL 54MM; 71352116 LEFT ANTEVERTED MODULAR NECK; UNK FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown