MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 - 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303203
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left tha was performed on (b)(6) 2016.After that, the patient developed pain and severe limp.Left revision surgery was performed in (b)(6) 2017 and taper femoral head.

• Brand Name: COCR 12/14 FEM HD 32 - 3
• 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: 9989018
• Report Number: 1020279-2020-01358
• Device Sequence Number: 3700031
• Product Code: LPH
• UDI-Device Identifier: 03596010194183
• UDI-Public: 03596010194183
• Combination Product (Y/N): N
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 03/26/2026
• Device Model Number: 71303203
• Device Catalogue Number: 71303203
• Device Lot Number: 16CM18532
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1