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

Model Number	75100474
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to a hip- peri-prosthetic hip fracture.The primary hip replacement procedure was (b)(6) 2020.The polarstem lateral size 1 and existing co-cr femoral head 32+4 were removed and the redapt femoral stem size 15h, 190mm and new cocr head 32+4 were implanted.
Additional Manufacturer Narrative
H11: d11 concomitant part added.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to peri-prosthetic hip fracture.Polarstem lateral size 1 (ref no.(b)(4)) and existing co-cr femoral head 32+4 (ref no.(b)(4) were explanted and revised.In this case the focus is on the investigations regarding the polarstem, which intent use is in treatment.The stem as well as clinical documentation weren't provided.A thorough product evaluation and clinical investigation could therefore not be performed.The product history review did not reveal any findings that could explain the reported bone fracture.The risk of bone or peri-prosthetic fracture is a known risk of a total endoprosthesis and is covered in our corresponding risk file as well as mentioned in the current instruction for use for hip implants lit.No.12.23 ed.(b)(6).At that time of investigation, the root cause cannot be determined.Should further information or the product get available the complaint will be reopened.Smith + nephew will monitor this device for similar issues.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to peri-prosthetic hip fracture.Polarstem lateral size 1 (ref no.(b)(4)) and existing co-cr femoral head 32+4 (ref no.(b)(4)) were explanted and revised.In this case the focus is on the investigations regarding the polarstem, which intent use is in treatment.The stem as well as clinical documentation weren't provided.A thorough product evaluation and clinical investigation could therefore not be performed.The product history review did not reveal any findings that could explain the reported bone fracture.The risk of bone or peri-prosthetic fracture is a known risk of a total endoprosthesis and is covered in our corresponding risk file as well as mentioned in the current instruction for use for hip implants lit.No.12.23 ed.05/16.At that time of investigation, the root cause cannot be determined.Should further information or the product get available the complaint will be reopened.Smith + nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 1 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10376878
• Report Number: 9613369-2020-00153
• Device Sequence Number: 11423748
• Product Code: LZO
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2020

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 Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: B1708512
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 10/01/2020; 09/30/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/06/2020; 10/02/2020; 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71303204 COCR 12/14 FEM HEAD 32 + 4.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention