MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM VALGUS TI/HA 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Model Number	75102074
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to periprosthetic fracture (calcar fracture) and subsidence of the polarstem.Patient felt pain 4 weeks prior to revision.No further information/ documents and no explants available (discarded).

• Brand Name: POLARSTEM VALGUS TI/HA 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• MDR Report Key: 6878270
• Report Number: 9613369-2017-00052
• Device Sequence Number: 566779
• Product Code: LZO
• UDI-Device Identifier: 07611996142341
• UDI-Public: (01)07611996142341(17)220510(10)B1505194
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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: 05/10/2022
• Device Model Number: 75102074
• Device Catalogue Number: 75102074
• Device Lot Number: B1505194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/24/2017
• 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: OXINIUM FEMORAL HEAD, PART 71343604, LOT 17CM20188
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR