MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71357108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/18/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fractured stem.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, as this complaint is being handled through smith nephew's legal team, any responses to these queries are not immediately available to the members of smith nephew's complaint/regulatory team and are not expected to be available for several months.This is due to the delivery timeframe of patient medical information and device return being in the control of the patient's legal team, rather than s&n.The s&n legal team has confirmed that once any additional relevant complaint information is received, (i.E.Reason for complaint, part/lot numbers, patient medical records, surgeon, device availability, and dates of implantation/revision) it will be provided to the complaint/regulatory team, at which point the complaint and or medical investigation task will be reopened for investigation.Therefore, a clinical assessment cannot be performed at this time.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 part revealed no prior complaints for the listed batch/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 8
• 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: 8634421
• Report Number: 1020279-2019-02031
• Device Sequence Number: 13863957
• Product Code: JDI
• UDI-Device Identifier: 03596010559630
• UDI-Public: 03596010559630
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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 Expiration Date: 03/10/2022
• Device Catalogue Number: 71357108
• Device Lot Number: 12CM07158
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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
• Patient Age: 59 YR