MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON PORUS

Model Number	71343612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received a revision surgery on (b)(6) 2020 due to dislocation, this was reported on (reported previously).Then, patient had heavy exudation wound post revision for instability, so patient received a washout and debridement with saline, iodine and peroxide.The r3 20 deg +4 xlpe acet lnr 36mm x 54mm and the oxinium fem hd 12/14 36 mm xl/+12 were removed.Shell and stem retained.Wound washed and irrigated.New implants of the same sizing were implanted.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that the patient had heavy exudating wound post revision for instability, so patient received a washout and debridement with saline, iodine and peroxide.The r3 20 deg +4 xlpe acet lnr 36mm x 54mm and the oxinium fem hd 12/14 36 mm xl/+12 were removed.Shell and stem retained.Wound washed and irrigated.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.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 review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Due to the limited information provided, no root cause for the reported event can be determined at this time.No further investigation is warranted for this complaint; however smith and nephew 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 36 MM XL/+12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON PORUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10693329
• Report Number: 1020279-2020-05479
• Device Sequence Number: 13596119
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• 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): 02/11/2021

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 Model Number: 71343612
• Device Catalogue Number: 71343612
• Device Lot Number: 18LM06061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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