MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71312112
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision hip surgery was performed due to femoral pain and loosening of stem, the liner was also exchanged.
Additional Manufacturer Narrative
[(b)(4)].

• Brand Name: SPEC EF PRIM HO 12/14 SZ 2
• 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: 6877895
• Report Number: 1020279-2017-00762
• Device Sequence Number: 1312132
• Product Code: LPH
• UDI-Device Identifier: 03596010195579
• UDI-Public: 03596010195579
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: Health Professional
• Device Catalogue Number: 71312112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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: Hospitalization; Other; Required Intervention