MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 32X 54-56 0 DG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71740254
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/01/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient suffered from hip dislocation and required reduction and/or manipulation under anesthesia to resolve.
Additional Manufacturer Narrative
The associated reflection acetabular liner was not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history did not reveal additional complaints for the listed batch.Our investigation could not determine a specific cause of the failure.A clinical evaluation noted that radiographic images from the primary and subsequent follow-up clinical study images were provided which don¿t give a root cause for the dislocation.Since the devices haven¿t been revised it¿s not possible to examine the components to identify a root cause for the dislocations.The extreme flexions noted are likely factors for the reported dislocations.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 be received, the complaint will be reopened.

• Brand Name: REF LNR 32X 54-56 0 DG SZ F
• 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 ; 0447940038246
• MDR Report Key: 8063938
• Report Number: 1020279-2018-02440
• Device Sequence Number: 1745487
• Product Code: LPH
• UDI-Device Identifier: 03596010231789
• UDI-Public: 03596010231789
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/14/2019
• 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 Expiration Date: 11/30/2017
• Device Model Number: 71740254
• Device Catalogue Number: 71740254
• Device Lot Number: 07MM00811
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 07/14/2023; 07/14/2023; 07/14/2023
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/16/2018; 07/15/2023; 12/15/2018; 02/14/2019
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2007
• 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: 71336254, 71332530, 71357009, 76539161
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female