MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SLEEVE/ STEM SEPARATOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIU

Catalog Number	71360919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Tip of screw portion broke off.Dr.Parcel determined that it was safer to patient to leave it implanted in the bone.Backup device was used.No delay to procedure, device is being returned.
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: SLEEVE/ STEM SEPARATOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7566007
• Report Number: 1020279-2018-01062
• Device Sequence Number: 1759396
• Product Code: MEH
• UDI-Device Identifier: 03596010535245
• UDI-Public: 03596010535245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: No Information
• Device Catalogue Number: 71360919
• Device Lot Number: 12FSY0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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: Other