MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303608
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the original thr was performed at (b)(6) hospital (b)(6) on (b)(6) 2015.Revision surgery was performed on (b)(6) 2020 due to loosening.The head was explanted.
Additional Manufacturer Narrative
It was reported that after five years of implantation a revision surgery was performed due to loosening.The affected cobalt chrome femoral head and cpcs cobalt chrome stem, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batches 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 adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.This reported failure has been identified in the instructions for use and risk management files as potential adverse events.Some potential causes of loosening could include but not limited to traumatic injury, fit/sizing, abnormal motion over time, poor bone ingrowth or osteolysis.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HEAD 36MM +8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9699383
• Report Number: 1020279-2020-00518
• Device Sequence Number: 19438636
• Product Code: LPH
• UDI-Device Identifier: 03596010480002
• UDI-Public: 03596010480002
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 01/25/2024
• Device Model Number: 71303608
• Device Catalogue Number: 71303608
• Device Lot Number: 14AM19420
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: Required Intervention