MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 260BW 15CAL SZ 12L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71340612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the femoral stem used in the patient who underwent revision hip surgery on (b)(6) 2018 broke on (b)(6) 2020.Patient reported that the breakage occurred while returning to sleep.

• Brand Name: ECH POR 260BW 15CAL SZ 12L
• 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: 9931455
• Report Number: 1020279-2020-01174
• Device Sequence Number: 19537576
• Product Code: LPH
• UDI-Device Identifier: 03596010383969
• UDI-Public: 03596010383969
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: No Information
• Device Expiration Date: 02/05/2026
• Device Model Number: 71340612
• Device Catalogue Number: 71340612
• Device Lot Number: 16BM05604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention