MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. POLARSTEM CEMENTLESS STEM STD TI.HA 9; PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CERAMIC/POLYMER,CMNTEDORNON-POROUS,UNCMNTD

Catalog Number	75100472
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to recurrent dislocations of left total hip arthroplasty.
Additional Manufacturer Narrative
Investigation results: the associated complaint devices were not returned.A clinical evaluation was conducted and without the primary implantation report, pre/post implantation x-ray, clinical documents we are unable to determine the root cause of the reported dislocations.In addition, without the implantation and pre-revision x-rays we are unable to determine the initial implant anatomical placement.However, based on the revision findings of a 15 degree decrease in the anterverson and 15 degree decrease in abduction, this cannot be ruled out as a likely contributory factor to the reported issue.The impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: POLARSTEM CEMENTLESS STEM STD TI.HA 9
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CERAMIC/POLYMER,CMNTEDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• MDR Report Key: 8195761
• Report Number: 1020279-2018-02890
• Device Sequence Number: 2165985
• Product Code: LZO
• UDI-Device Identifier: 07611996118636
• UDI-Public: 07611996118636
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 07/28/2021
• Device Catalogue Number: 75100472
• Device Lot Number: A1408723
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 05/07/2019
• 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: Other; Required Intervention
• Patient Age: 71 YR