MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 15; PRSTHSIS, HIP,SEMICNSTRNED,MTAL/PLYMR,POROUSUNCMNTD

Catalog Number	71306115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performd due to infection.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A clinical investigation concluded that no clinically relevant documentation was provided to perform a thorough medical investigation; however, per complaint the revision was due to infection.The patient impact beyond probable antibiotic treatment and the reported revision itself cannot be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.Without the return of the actual product involved information, our investigation of this report is inconclusive.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SYN POR HO FEM COM SZ 15
• Common Device Name: PRSTHSIS, HIP,SEMICNSTRNED,MTAL/PLYMR,POROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7282271
• Report Number: 1020279-2018-00210
• Device Sequence Number: 1177556
• Product Code: LPH
• UDI-Device Identifier: 03596010291998
• UDI-Public: 03596010291998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 03/22/2025
• Device Catalogue Number: 71306115
• Device Lot Number: 15CM17354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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
• Patient Age: 58 YR