MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLUS SL STD STEM 3; PRSTHSIS,HIP, SMI-CNSTRAIND, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75002699
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Bipolar head and inner head were removed and antibiotic-loaded cement was placed.Stem was remained.
Additional Manufacturer Narrative
Please disregard report 1020279-2018-01829.The sl-plus standard stem 3 non-cemented, part number: 75002699, lot number: g1703597, remained inside the patient and was not revised.There is no product failure or patient condition alleged in relationship with this device.Refer to the revised components to 1020279-2018-01845 and 1020279-2018-01844 for the inner insert and head, respectively.

• Brand Name: PLUS SL STD STEM 3
• Common Device Name: PRSTHSIS,HIP, SMI-CNSTRAIND, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7908662
• Report Number: 1020279-2018-01829
• Device Sequence Number: 19281910
• Product Code: LZO
• UDI-Device Identifier: 07611996078657
• UDI-Public: 07611996078657
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072852
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

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: 75002699
• Device Lot Number: G1703597
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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
• Patient Age: 71 YR