MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 2 NON-CEM; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED, UNCEMENTED

Catalog Number	75100475
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was reported to correct a stem subsidence and a periprothetic fracture.The surgeon thinks that the cause of this event is due to the stem being undersize.
Additional Manufacturer Narrative
Results: a revision surgery was reported due to stem subsidence.No product was returned for investigation.No batch number was communicated.Minimal patient information and no medical documents were received for investigation.Therefore no medical assessment could be performed.The reported issue cannot be confirmed.The information available is insufficient to determine any root cause.No further actions are deemed necessary.

• Brand Name: POLARSTEM STEM LAT.TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau, CH500 0; SZ CH5000
• MDR Report Key: 7814816
• Report Number: 9613369-2018-00052
• Device Sequence Number: 11159491
• Product Code: LZO
• UDI-Device Identifier: 07611996118667
• UDI-Public: 07611996118667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: Lay User/Patient
• Device Catalogue Number: 75100475
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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
• Patient Age: 70 YR