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

Model Number	75100463
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after undergoing a right thr on (b)(6) 2013 due to osteoarthritis, the patient experienced a peri-prosthetic fracture near the stem.This adverse event was treated by performing a revision surgery on (b)(6) 2022.During this procedure, the femoral stem, acetabular cup, modular head, and acetabular liner were removed and replaced with competitor's devices (stryker).This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem stem with an r3 acetabular cup and that required a revision surgery due to specific reasons.As such, no further information will be available.
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry from united kingdom that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: POLARSTEM STEM STD TI/HA 0 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: 16282957
• Report Number: 9613369-2023-00103
• Device Sequence Number: 6766530
• Product Code: LZO
• UDI-Device Identifier: 07611996118544
• UDI-Public: 07611996118544
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: 07/14/2020
• Device Model Number: 75100463
• Device Catalogue Number: 75100463
• Device Lot Number: A1309006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/02/2023
• Date Device Manufactured: 07/16/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OX FEM HD 12/14 32MM +0(PN:71343200,LN:13GM13420); R3 20D ACT LNR 32MMX50MM(PN:71337650,LN:13FM07502); R3 3HL HA ACT SHLL 50MM(PN:71331950,LN:13GM00117)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female