MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100464
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha the patient required a revision surgery, the cause is unknown.The adverse event was treated by a revision procedure on (b)(6) 2021.Current health status of patient and further details are not available at this time.
Additional Manufacturer Narrative
Results of investigation: it was reported that, after a tha the patient required a revision surgery, the cause is unknown.The adverse event was treated by a revision procedure on (b)(6) 2021.Current health status of patient and further details are not available at this time.The device in scope is a polarstem stem std ti/ha 1 non-cem, which intent use is in treatment.The stem was returned for investigation and shows some heavy signs and scratches which indicates a vigorous and difficult extraction.The extractor block sticks on the neck of the stem and cannot be easily removed.For the batch in scope no additional complaint was recorded.No complaint evaluation on part level was conducted due to insufficient information about the root cause for revision.No deviations found in the corresponding batch record, which could explain the occurred revision surgery.The failure mode can not be confirmed.To date smith and nephew has not received adequate clinical materials to fully evaluate the complaint.The visual inspection of the extracted stem and the product history review do not allow any conclusions to be drawn about the reason for the revision.The root cause can not be established and no potential contributing factor can be identified.In our current ifu for hip implants several causes are stated which could lead to a revision surgery.The risk of an adverse event is covered within our risk file.To date no corrective or preventive actions are planned.The case will be closed.If additional clinically relevant materials are later received, then the case will be re-opened for further evaluation.Smith + nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12355460
• Report Number: 9613369-2021-00348
• Device Sequence Number: 11866622
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B1917489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown