MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71332760
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The surface of removed liner and ox head was damaged and found that there have been lot of scratches.No delay or back up reported.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated that the as- received components are showed scratches on the outer diameter of the femoral head.Edx analysis showed traces of zirconium, iron, and cobalt indicating that the femoral head came in contact with an instrument, resulting in the gouges and scratches.Scratches were seen on the liner¿s articulating surface in a circular pattern.This indicates that a particulate (bone cement, bone chip, etc.) was between the femoral head and liner in vivo.No manufacturing or material deviations were identified in this investigation.A clinical analysis indicated that based on the complaint information, the revision tha was required due to the reported pseudomonas aeruginosa infection.Per explant analysis, the noted deformation to the liner head was indicative of 3rd body particulate in vivo and the femoral head gouge was due to instrumentation contact.The patient impact was the reported infection and resultant revision with an expected post-surgical convalescence phase which likely included antibiotic therapy.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.The quality team for this product has been made aware of this complaint.Based on this investigation, the need for corrective action is not indicated; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 60MM
• 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: 8065062
• Report Number: 1020279-2018-02447
• Device Sequence Number: 2389326
• Product Code: JDI
• UDI-Device Identifier: 03596010598028
• UDI-Public: 03596010598028
• Combination Product (Y/N): N
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 71332760
• Device Lot Number: 17FM10906
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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