MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 6; PROSTHESIS,HP,SM-CNSTRND,MTL/PLYMER,CEMENTED

Model Number	71357106
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.A full set of smith and nephew implants were reimplanted.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 6
• Common Device Name: PROSTHESIS,HP,SM-CNSTRND,MTL/PLYMER,CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9601652
• Report Number: 1020279-2020-00308
• Device Sequence Number: 19565059
• Product Code: JDI
• UDI-Device Identifier: 03596010559616
• UDI-Public: 03596010559616
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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 Model Number: 71357106
• Device Catalogue Number: 71357106
• Device Lot Number: 19JM05788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention