MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 0 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED

Model Number	75100463
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery of the stem was performed due to medial calcar fracture.
Additional Manufacturer Narrative
It was reported that revision surgery of a polarstem (75100463) was performed due to a medial calcar fracture.The device used in treatment was not returned for investigation.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.To date no medical records have been received.Without any supporting medical documentation, the reported event could not be assessed, and a thorough medical assessment could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint reported for a similar issue for the in scope device.The ifu (lit.No.12.23 ed.05/16) identifies bone fractre as a known possible side effect resulting from a total hip arthroplasty.Based on available information the root cause for the reported bone fracture could not be determined.However, there is no indication that the device failed to match specification at the time of manufacturing.The associated risk is covered in the risk analysis and considered low.Therefore and based on available information, the need for corrective action is not indicated.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 0 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: 9545904
• Report Number: 9613369-2020-00001
• Device Sequence Number: 16805091
• Product Code: LZO
• UDI-Device Identifier: 07611996118544
• UDI-Public: 07611996118544
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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 Expiration Date: 07/15/2026
• Device Model Number: 75100463
• Device Catalogue Number: 75100463
• Device Lot Number: B1915027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: Hospitalization; Required Intervention