MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTH, HIP, SEMI-CONSTRAINED, MET/POLY, CEMENT

Catalog Number	71343604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an excellent recovery from the primary surgery ((b)(6) 2020), but about four weeks ago, developed a wound ooze which did not improve with wound care and antibiotics, so a washout was performed ((b)(6) 2020).The pathology revealed that it was pseudomonas and staphylococcus.Therefore, a revision surgery, washout and debridement was performed via the previous incision.The head was removed.Surgeon stated that the hip was stable and that the patient health was satisfactory.
Additional Manufacturer Narrative
It was reported that the patient developed a wound ooze which did not improve with wound care and antibiotics, so a washout was performed.The pathology revealed that it was pseudomonas and staphylococcus.The affected complaint, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the symptoms (ooze) reportedly appeared approximately 2 weeks post implantation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Common Device Name: PROSTH, HIP, SEMI-CONSTRAINED, MET/POLY, CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10109048
• Report Number: 1020279-2020-01933
• Device Sequence Number: 3122461
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 3596010477286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71343604
• Device Lot Number: 19JM00709
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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