MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +4; PROSTH, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEM OR NON-POR, UNCE

Model Number	71343204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery and a washout were performed due to infection.The liner and head were replaced.The primary surgery was performed on (b)(6) 2020.
Additional Manufacturer Narrative
It was reported that a washout performed due to infection.Liner and head removed and replaced.The affected oxinium femoral head and r3 acetabular liner, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.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 devices and the reported incident could not be corroborated.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the risk management files identified the reported failure as potential adverse events.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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no medical records provided, our investigation of this report is inconclusive.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 additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 32MM +4
• Common Device Name: PROSTH, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEM OR NON-POR, UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10003205
• Report Number: 1020279-2020-01394
• Device Sequence Number: 19356053
• Product Code: LZO
• UDI-Device Identifier: 03596010474223
• UDI-Public: 03596010474223
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 71343204
• Device Catalogue Number: 71343204
• Device Lot Number: 19KM11098
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/21/2020
• 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