MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 12 L; PRSTH,HP,SM-CNSTRN,NCMN,MTL/PLY,NN-PRS,CLCM-PHSPHT

Model Number	71344412
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to loosening after a fall onto the left hip, subsequent to a first revision hip surgery.Implanted devices: size 15 left 260 standard echelon stem with associated ceramic head 32 +4.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loosening after a fall onto the left hip.Once opened, it was discovered the stem was very loose.The affected echelon coated stem and biolox delta head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.As reported, potential cause of loosening is probably the patient traumatic injury.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: ECHELON HA STD 260 BOW S 12 L
• Common Device Name: PRSTH,HP,SM-CNSTRN,NCMN,MTL/PLY,NN-PRS,CLCM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9706231
• Report Number: 1020279-2020-00535
• Device Sequence Number: 14308334
• Product Code: MEH
• UDI-Device Identifier: 00885556023549
• UDI-Public: 00885556023549
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 12/12/2022
• Device Model Number: 71344412
• Device Catalogue Number: 71344412
• Device Lot Number: 07BM14829C
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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
• Patient Age: 66 YR