MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED

Model Number	75018956
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Patient had diabetic reflux and hypertension.Surgeon used previous incision to open joint and dislocated the hip.Head and liner was removed via punch.Stem was removed via flexible osteotomes and removal tool.Cup removed by explant.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.The devices (polarcup shell 75100409; polarcup insert 75018956; polarstem 75100464) used in treatment were not returned for investigation.An appropriate investigation could therefore not be conducted and the reported infection could not independently be confirmed.To date no medical records have been received.Without any supporting medical documentation, the reported event cannot be assessed and a thorough medical assessment cannot be performed.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported infection.Review of the risk management documentation verifies the failure mode and severity of the reported issue.The risk associated with infection is considered low for all three devices in scope.The ifu (lit.No.12.23 ed 05/16) identifies "infection" as a known possible side effect resulting from a hip arthroplasty.One additional complaint has been reported for infection for the same batch (b1917935) of the polarcup xlpe insert.Both complaints are originated in australia and from the same hospital.However, there is no indication that the devices failed to match sterilization or other specifications at the time of manufacturing.Based on available information the root cause for the reported infection cannot be determined.Therefore and based on available information, the need for corrective action is not indicated.Nevertheless, further investigations have been initiated to ensure the safety and efficacy of devices related to batch b1917935.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device or additional information be received.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9794025
• Report Number: 9613369-2020-00051
• Device Sequence Number: 16768010
• Product Code: LZO
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• Combination Product (Y/N): N
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: No Information
• Device Expiration Date: 06/15/2026
• Device Model Number: 75018956
• Device Catalogue Number: 75100464
• Device Lot Number: B1912771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: Required Intervention