MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIGH OFFSET NEUTRAL MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, due to infection, 3 hip devices were removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical group concluded, no clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: HIGH OFFSET NEUTRAL MODULAR NECK
• 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: 7490627
• Report Number: 1020279-2018-00889
• Device Sequence Number: 1513182
• Product Code: LPH
• UDI-Device Identifier: 03596010619549
• UDI-Public: 03596010619549
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: 71352112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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: Required Intervention