MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +0; PROSTHESIS, HIP, SEMI-CONSTRAIND, METAL/POLYMER, POROUS UNEMENTD

Model Number	71303600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a right thr via the posterior approach using anthology r3 construct.The patient presented late-onset infection years after surgery.Dr.Decided to do the right side first stage revision thr, removal of36mm +0 cocr 12/14 femoral head was performed in situ on (b)(6) 2020 at (b)(6).Full second stage revision will be performed once infection subsides.
Additional Manufacturer Narrative
It was reported that the patient presented late-onset infection years after surgery.Dr.Decided to do the right side first stage revision thr.Full second stage revision will be performed once infection subsides.The associated devices, used in treatment, were not returned for evaluation.Thus the product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.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 could not be corroborated.This reported failure has been identified in the instructions for use and risk management files.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Some potential causes of the reported event could include but are not limited to patient medical condition or patient reaction.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 additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HEAD 36MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIND, METAL/POLYMER, POROUS UNEMENTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9926302
• Report Number: 1020279-2020-01149
• Device Sequence Number: 2817689
• Product Code: LPH
• UDI-Device Identifier: 03596010479983
• UDI-Public: 03596010479983
• Combination Product (Y/N): N
• PMA/510(K) Number: K022902
• 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): 07/23/2020

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: Health Professional
• Device Expiration Date: 07/25/2026
• Device Model Number: 71303600
• Device Catalogue Number: 71303600
• Device Lot Number: 16GM17634
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 04/05/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1