MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 2; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75018402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery took place on (b)(6) 2021 due to a femoral stem subsided.It was replaced with a bigger implant.Implants removed were r3 us delta head 32 +4 and polarstem collar std.Ti/ha 2.There are no thoughts from the surgeon that the implant failed.He believes it was undersized.Primary surgery took place on (b)(6) 2019.
Additional Manufacturer Narrative
It was reported that a revision surgery took place on (b)(6) 2021 due to a polarstem collar std.Ti/ha 2 subsided.It was replaced with a bigger implant.There are no thoughts from the surgeon that the implant failed.He believes it was undersized.The clinical root cause of the subsidence and subsequent revision is related to the ¿undersized femoral stem and is not related to a malperformance of the implant.No further medical assessment is warranted at this time.To date the claimed stem, which intent use is in treatment, was not returned for investigation.A product history review was performed but no indications were found which could explain occurred failure for the device.No similar complaint can be found.The risk of an implant migration is covered within our current risk file and rated as low.In our current instruction for use for hip implants [lit.12.23, ed.05/16] a repositioning of the implant is a known and possible side effect of a total hip implantation.After the performed investigations the root cause for this implant migration can not be stated.The case will be closed.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM COLLAR STD. TI/HA 2
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11478996
• Report Number: 9613369-2021-00114
• Device Sequence Number: 11616180
• Product Code: LZO
• UDI-Device Identifier: 07611996103397
• UDI-Public: 07611996103397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 75018402
• Device Catalogue Number: 75018402
• Device Lot Number: B1916780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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