MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM SO 12/14 SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312364
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision hip surgery was performed due to fracture cement mantle and subsidence cpcs femoral component.
Additional Manufacturer Narrative
The associated cpcs collarless polished cemented standard offset stem and oxinium femoral head were returned and evaluated.A lab analysis conducted during this investigation noted that visual examination of stem component found surface marks on the a-p sides of the neck.These markings most likely occurred during removal of the stem from contact of an instrument.The distal tip exhibited some minor burnish marks.It is unclear but potentially this is the result of motion between the femoral component and cement mantle given subsidence reported.Examination of the head did not reveal any significant observations.Some minor scars were noted on the articular surface.These most likely are the results of instrument contact during the removal procedure.There is no evidence to indicate either of the components played a role in this issue.The reason for the fractured cement mantle cannot be determined from information provided.Our investigation including 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 reported incident or adverse event could not be corroborated.A clinical analysis noted there was likely micromotion as a root cause.Aggressive femoral reaming and the subsequent thick cement mantle could have been contributing factors to the reported event.The patient impact beyond the reported revision cannot be determined.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.

• Brand Name: CPCS COCR PRIM SO 12/14 SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8643495
• Report Number: 1020279-2019-02056
• Device Sequence Number: 10826718
• Product Code: JDI
• UDI-Device Identifier: 03596010462039
• UDI-Public: 03596010462039
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 06/21/2025
• Device Catalogue Number: 71312364
• Device Lot Number: 15FM18206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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