MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN HA PF FEM COMP SZ 15; PRSTHSISHIPSMICNSTRINDUNCMNTDMTALPLYMRNONPORUSCLICUMPHSPHT

Model Number	71306715
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to femoral neck fracture.Stem and femoral head were explanted and replaced for zimmer biomet stem.

• Brand Name: SYN HA PF FEM COMP SZ 15
• Common Device Name: PRSTHSISHIPSMICNSTRINDUNCMNTDMTALPLYMRNONPORUSCLICUMPHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9902734
• Report Number: 1020279-2020-01090
• Device Sequence Number: 2717822
• Product Code: MEH
• UDI-Device Identifier: 03596010194596
• UDI-Public: 03596010194596
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970337
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: 71306715
• Device Catalogue Number: 71306715
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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