MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 13; PROSTHE, HIP, SEMI-CONS, UNCEME, MET/POLY, NON-PORO, CALICUM-PHOSP

Model Number	71309113
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized due to leg pain.This was treated via nerve root block (injection).
Additional Manufacturer Narrative
It was reported that the patient was hospitalized due to leg pain.The affected r3 delta ceramic liner, biolox delta head, r3 acetabular shell and synergy porous plus high offset stem, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted there was no septic etiology reported and this adverse event was treated via nerve root block (injection).No revision surgery has been scheduled or performed yet.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but not limited to traumatic injury, patient reaction or joint tightness.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: SYN POR PLUS HA HO STEM SZ 13
• Common Device Name: PROSTHE, HIP, SEMI-CONS, UNCEME, MET/POLY, NON-PORO, CALICUM-PHOSP
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9446740
• Report Number: 1020279-2019-04358
• Device Sequence Number: 16704914
• Product Code: MEH
• UDI-Device Identifier: 03596010459787
• UDI-Public: 03596010459787
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: foreign,study,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: No Information
• Device Expiration Date: 04/22/2018
• Device Model Number: 71309113
• Device Catalogue Number: 71309113
• Device Lot Number: 08CM06412A
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 04/16/2020
• 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