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 a revision surgery was performed due to infection.Primary surgery was performed on (b)(6) 2019.Patient left hip wound would not heal and was infected.Patient had a washout and debridement prior to first stage revision on (b)(6) 2019, acetabular implants and femoral component were removed.Antibiotic cement spacer implanted.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.The complained devices have not been returned for investigation and the reported failure mode could therefore not independently be confirmed.No clinical supporting documents have been provided for the inclusion in the medical assessment.A thorough medical assessment could therefore not be conducted.Three out of five batch numbers in scope have been communicated.No deviations from the standard manufacturing process were revealed for these batch records.Sterilization was conducted according to procedure and within specification.Based on available information the root cause for the reported infection cannot be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the devices for similar issues.The complaint will be reopened should additional information or the complained devices be received.

• 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: 8468041
• Report Number: 1020279-2019-01270
• Device Sequence Number: 16538017
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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 Catalogue Number: 121010
• Device Lot Number: 18GSM0212
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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