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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to replace implants stryker all poly cup, cpcs stem and head due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.The devices were manufactured in 2013, 2014 and 2015.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 complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Products were sterilized according to sterilization release documentation from quality control.A clinical investigation was conducted and it concluded that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The reported infection was the contributing factor to the left tha revision; however without the supporting lab/pathology results, operative notes, and/or explanted components, the source of the infection cannot be confirmed.The patient impact beyond the reported symptoms, left hip revision/first stage, likely antibiotic therapy, and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 7880963
• Report Number: 1020279-2018-01815
• Device Sequence Number: 1939625
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 05/01/2023
• Device Catalogue Number: 71312364
• Device Lot Number: 13EM02949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2018
• Supplement Date Received by Manufacturer: 08/19/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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; Other; Required Intervention