MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM CEMENTLESS STEM LAT TI.HA 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100479
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to delayed hip prosthesis infection.
Additional Manufacturer Narrative
Results of investigation: a revision surgery of a polarstem due to delayed hip prosthesis infection was reported.No part was returned for investigation.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No deviations were detected on the sterilization certificate.No similar complaint was reported for this batch of products.No medical documents were received for investigation.Based on the available information, no thorough investigation could be performed and the root cause of the reported issue remains undetermined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.No further actions have been initiated.If the explants or additional information becomes available in the future this investigation will be reopened.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; memphis, tennessee; baar 06340 ; SZ 06340
• MDR Report Key: 7950203
• Report Number: 1020279-2018-02133
• Device Sequence Number: 13831485
• Product Code: LZO
• UDI-Device Identifier: 07611996118704
• UDI-Public: 07611996118704
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130728
• 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): 01/15/2019

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 Expiration Date: 07/18/2022
• Device Catalogue Number: 75100479
• Device Lot Number: B1508633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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: Other; Required Intervention
• Patient Age: 75 YR