MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POROUS SZ 11; PRSTHSS,HIP,SMCNSTRND,MTLPLYMR,CMENTD

Catalog Number	71356011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
(b)(4).Mdr reference no.1020279-2018-00069/1020279-2018-00070/1020279-2018-00090.Dear ladies and gentlemen, following receipt of additional information concerning this case, it has been determined that the initial report was submitted in error.Please therefore disregard this report.This issue was already reported under 1020279-2018-00074.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ANTHOLOGY SO POROUS SZ 11
• Common Device Name: PRSTHSS,HIP,SMCNSTRND,MTLPLYMR,CMENTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7206776
• Report Number: 1020279-2018-00069
• Device Sequence Number: 19058638
• Product Code: JDI
• UDI-Device Identifier: 03596010567819
• UDI-Public: 03596010567819
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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 Expiration Date: 12/28/2018
• Device Catalogue Number: 71356011
• Device Lot Number: 08MM19230
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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