MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303604
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery to remove a cocr femoral head, part of a 2012 tkr.The patient presented metal wear debris around the soft tissue and the taper junction from the femoral head appeared to have corrosion.
Additional Manufacturer Narrative
It was reported that the patient underwent revision surgery to remove a cocr femoral head.The patient presented metal wear debris around the soft tissue and the taper junction from the femoral head appeared to have corrosion.The associated femoral head, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted that a visual inspection of the device found some minor gouges on the distal chamfer of the head, this was most likely due to removal.The taper surface has visual evidence of corrosion.No material or manufacturing deviations were observed in this report.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Based on this investigation, the need for corrective action is not indicated.This reported failure has been identified in the instructions for use and risk management files as potential adverse events.Per ifu, wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HEAD 36MM +4
• 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: 9752061
• Report Number: 1020279-2020-00707
• Device Sequence Number: 16325389
• Product Code: LPH
• UDI-Device Identifier: 03596010479990
• UDI-Public: 03596010479990
• 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: 2012
• 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): 07/08/2020

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: 06/25/2022
• Device Model Number: 71303604
• Device Catalogue Number: 71303604
• Device Lot Number: 12FM17040
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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