MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 5; METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED

Catalog Number	75000190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in a revision surgery was performed due to infection.The sl-plus stem was removed.
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.As the batch number of the device in question was not communicated, a batch record review and a complaint history review could not be performed.Infection is a known side effect, according to ifu lit.No.12.23 ed.On (b)(6).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.Smith and nephew will monitor this device for further similar incidents.

• Brand Name: SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 5
• Common Device Name: METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 10059245
• Report Number: 9613369-2020-00084
• Device Sequence Number: 3292901
• Product Code: LZO
• UDI-Device Identifier: 07611996092929
• UDI-Public: 7611996092929
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2020

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 Catalogue Number: 75000190
• Distributor Facility Aware Date: 04/16/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 08/09/2020
• 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