MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. POLARSTEM CEMENTLESS STEM LAT TI.HA 2; PROSTHESIS,HIP,SEMICONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTEDNONPOROUS

Catalog Number	75100475
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported right hip pain.It is unknown the reason for the pain or if a revision surgery has been performed.
Additional Manufacturer Narrative
Results of investigation: the associated complaint devices were not returned.The clinical/medical team concluded, no clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 2
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTEDNONPOROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• MDR Report Key: 8244866
• Report Number: 1020279-2019-00154
• Device Sequence Number: 2288385
• Product Code: LZO
• UDI-Device Identifier: 07611996118667
• UDI-Public: 07611996118667
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 11/29/2024
• Device Catalogue Number: 75100475
• Device Lot Number: B1718645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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: 72 YR