MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN CEM HO FEM COMP SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71316211
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	03/23/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had progressive tight pain, and that x-rays were consistent with femoral component loosening showing lucency around femoral component with slight varus migration of the femoral stem.Femoral stem and femoral head were revised.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.

• Brand Name: SYN CEM HO FEM COMP SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6995648
• Report Number: 1020279-2017-00966
• Device Sequence Number: 13748415
• Product Code: JDI
• UDI-Device Identifier: 03596010410573
• UDI-Public: 03596010410573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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 Expiration Date: 03/04/2018
• Device Catalogue Number: 71316211
• Device Lot Number: 08CM03820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 36 MM +0, 71343600/08BM22013
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR