MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PREP IM ENCHANCE TOTAL HIP KIT; CEMENT OBTURATOR

Catalog Number	121010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a left side tha at (b)(6) public (b)(6) 2019 with a spectron/polarcup construct via a posterior approach.Patient has medical history of kidney transplant.Patient left hip wound would not heal and was infected.Patient had a washout and debridement (done by another surgeon) as well as vac dressings, prior to first stage revision on (b)(6) 2019.Dr.Performed first stage revision hip surgery on (b)(6) 2019 removing acetabular implants with zimmer explant and using renovation hip to remove femoral component.Surgeon performed an eto and removed cement from femur with renovation instruments.Acetabulum reamed and femur reamed.Wound debrided and irrigated with saline and betadine and femur cabled with circlage wire temporarily.Wound closed, and then pt re-prepped and draped with whole new setup.Pt then reopened and then dallmiles cables applied to femur and zb hip cement spacer inserted with palacos copal cement loaded with antibiotic used to fix hip cement spacer.Wound irrigated and closed in layers.

• Brand Name: PREP IM ENCHANCE TOTAL HIP KIT
• Common Device Name: CEMENT OBTURATOR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8489189
• Report Number: 1020279-2019-01400
• Device Sequence Number: 16816559
• Product Code: LZN
• UDI-Device Identifier: 03596010457127
• UDI-Public: 03596010457127
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K791125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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 Catalogue Number: 121010
• Device Lot Number: 18GSM0212
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/05/2019
• 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