MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 32X 50-52 20DG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71743250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to poly wear.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

• Brand Name: REF LNR 32X 50-52 20DG SZ E
• 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: 7071092
• Report Number: 1020279-2017-01162
• Device Sequence Number: 16536987
• Product Code: LPH
• UDI-Device Identifier: 03596010232328
• UDI-Public: 03596010232328
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 71743250
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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; Required Intervention