MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 6; PRSTHSIS HIP SEMI-CNSTRNED CERAMIC/METAL CMNTD OR UNCMNTD

Catalog Number	71357106
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr removed a size 6 high offset anthology stem and replaced it with a size 8 high offset stem due to recurrent dislocation.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 6
• Common Device Name: PRSTHSIS HIP SEMI-CNSTRNED CERAMIC/METAL CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6884605
• Report Number: 1020279-2017-00767
• Device Sequence Number: 760912
• Product Code: MRA
• UDI-Device Identifier: 03596010559616
• UDI-Public: 03596010559616
• Combination Product (Y/N): N
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: 71357106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention