MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335758
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported at first stage revision left hip, where the patient had infection.A revision hip was done originally on the (b)(6) 2017 after a periprosthetic fracture.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this is a complaint from (b)(6) reporting the first stage of a 2nd revision of the left hip.The primary surgery was performed in 2012.The 1st revision was done on (b)(6) 2017 secondary to a periprosthetic fracture secondary to a fall.This 1st stage of the 2nd revision was performed on (b)(6) 2018 secondary to an infection.A laboratory chemistry sheet, dated (b)(6) 2018 was submitted, but did not add to this assessment.Also 1 x-ray of the bilateral hips dated (b)(6) 2018.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the limited available information, the root cause/source of the infection cannot be concluded.No current information on the patient¿s status has been submitted.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7773325
• Report Number: 1020279-2018-01510
• Device Sequence Number: 1392512
• Product Code: MBL
• UDI-Device Identifier: 03596010598363
• UDI-Public: 03596010598363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: 71335758
• Device Lot Number: 16MM17079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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