MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS DIST CENT SZ 10MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Loan: (b)(4).Product experience original surgery: dr (b)(6) approx 2 weeks ago (b)(6).Revision cause: infection.Case: cpcs size 2 ho cemented stem removed.Cpcs size 1 ho stem implanted in remaining cement mantle.Size 36 +8 cobalt chrome head removed.New head implanted (same size and material).No report required for surgeon.Surgeon has not implicated implant as a cause of revision.No hospital report required.Implant will not be returned to the hospital.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.A review of the production documentation for the corresponding products 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 batches.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: CPCS DIST CENT SZ 10MM
• 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: 7485629
• Report Number: 1020279-2018-00847
• Device Sequence Number: 13479992
• Product Code: JDI
• UDI-Device Identifier: 03596010466983
• UDI-Public: 03596010466983
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/10/2018

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: Lay User/Patient
• Device Catalogue Number: 71312410
• Device Lot Number: 18AM17709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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; Required Intervention