MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 12 R; PROSTHESIS, HIP, SEMICONSTRAIND,UNCMNTD, METAL/POLYMR,NPOROUS, CALICUMPHOSPHATE

Catalog Number	71345512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the patient presented a stress fracture of a size 12- 260mm echelon stem.Revision surgery was performed replacing the echelon stem with a size 13h sleeved (medium sleeve) stem & replacement ceramic head.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no clinical/medical information has been forthcoming.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 production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: ECHELON HA STD 260 BOW S 12 R
• Common Device Name: PROSTHESIS, HIP, SEMICONSTRAIND,UNCMNTD, METAL/POLYMR,NPOROUS, CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8074177
• Report Number: 1020279-2018-02494
• Device Sequence Number: 19265551
• Product Code: MEH
• UDI-Device Identifier: 00885556022344
• UDI-Public: 00885556022344
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 09/20/2026
• Device Catalogue Number: 71345512
• Device Lot Number: 16GM02172A
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 76539166/16GT73000; 76539166/16GT73000
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention