MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT FULLY POROUS SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71354234
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.This was an ongoing issue the patient already underwent a closed reduction due to dislocation on (b)(6) 2017.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that this complaint is submitted from the redapt retrospective study, reporting a revision secondary to a ¿dislocations¿ causing an ongoing issue and required a revision¿.No clinical/medical documents were provided for the investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include device loosening or improper selection.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.This was an ongoing issue the patient already underwent a closed reduction due to dislocation on 30 may 2017.

• Brand Name: REDAPT FULLY POROUS SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9315159
• Report Number: 1020279-2019-03992
• Device Sequence Number: 2616488
• Product Code: LPH
• UDI-Device Identifier: 00885556321447
• UDI-Public: 00885556321447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 12/14/2025
• Device Model Number: 71354234
• Device Catalogue Number: 71354234
• Device Lot Number: 15MM12810
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention