MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75000176
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had implanted smith and nephew devices.The patient was experienced infection and fever.Revision surgery is planned to resolve this issue on (b)(6) 2020.The doctor says the devices are not defective.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 a revision surgery had to be performed due to infection.During this surgery, an sl-plus integration mia stem lat.Was removed.The device, used in treatment, was not returned for evaluation.The production documentation and the sterilization certificate was reviewed, there were no deviations found.There was no additional complaint reported for the batch in scope.Infection is a possible side effect, according to ifu lit.No.12.23 ed.(b)(6) 2016.The severity and the failure mode of the reported incident are covered in the corresponding risk management files.There was no further medical information provided, therefore a thorough assessment could not be performed.The reported failure mode cannot be confirmed, based on the available information.Also the root cause of the infection cannot be established.To date, there are no actions deemed necessary.Should the device or further information become available, this complaint will be reopened.Smith and nephew will monitor this device for further similar incidents.

• Brand Name: SL-PLUS INTEGR MIA STEM WITH TI/HA 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• MDR Report Key: 10604087
• Report Number: 9613369-2020-00187
• Device Sequence Number: 3934517
• Product Code: LWJ
• UDI-Device Identifier: 07611996092783
• UDI-Public: 07611996092783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: Health Professional
• Device Model Number: 75000176
• Device Catalogue Number: 75000176
• Device Lot Number: C2001843
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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