MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 2 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75100465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case-(b)(4).
Event or Problem Description
It was reported that patient had a primary thr on (b)(6) 2020 and showed signs of infection and this was confirmed by pathology.Revision surgery performed using cpcs and all poly reflection cup with copal antibiotic cement.
Additional Manufacturer Narrative
Investigation results: it was reported that patient had a primary total hip replacement showed signs of infection and this was confirmed by pathology.Revision surgery performed using cpcs and all poly reflection cup with copal antibiotic cement.The claimed article, a polarstem stem std ti/ha 2 non-cem which intent use is in treatment, was not returned for investigation.A product history review was performed.The corresponding batch record shows no deviation which could relate to the reported infection.No other complaint can be found for the batch in question.The risk file shows that the risk of an infection is covered and rated as low.In our current instruction for use for hip implants 12.23 ed.06/20 an infection is a known and mentioned possible side effect of a total hip replacement.To date smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.No device problem can be found and the cause is not established.If additional clinically relevant materials are later received, then the case will be re-opened for further evaluation.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11355518
• Report Number: 9613369-2021-00076
• Device Sequence Number: 19862928
• Product Code: KWY
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: B2011112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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