MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 6 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	75100469
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Pelvic Pain (4865)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint polarstem used in treatment was returned for investigation.Additionally, two concomitant devices, an unknown ball head and a r3 xlpe liner, were returned.A visual evaluation was conducted, and it was concluded that the neck of the stem implant is fractured.Further, whitish residues are visible throughout the stem shaft.On the other side of the shaft, heavy scratches are visible.It is suspected that they arose from the explantation.The distal side of the ball head is heavily scratched.Further, the broken-off fragment from the stem is stuck inside the ball head.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with a similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use ifu 81098832 rev.B states "fracture of implant, bone or cement" as a ¿possible side effect¿ in combination with the implantation of a hip prosthesis.Product drawings and inspection instruction were reviewed.No indication was detected which could have contributed to the reported failure mode.An assessment of material characteristics was performed, and it was concluded that about two thirds of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue.The residual fracture surface is covered by dimples, characteristic of ductile overload.No pores, inclusions or elemental inhomogeneities which could have initiated or enhanced crack growth, could be observed on the fracture surface.On both distal and proximal neck surfaces, discolorations close to the assumed crack initiation site are present, indicating the use of an electric scalpel during explantation surgery.The available clinical information was reviewed.Based on the information provided, the reported fall on the operative side likely caused the femoral polarstem fracture within the right hip prosthesis and subsequent revision, as confirmed by clinical and radiographic findings.Possible micromotion may be a factor but cannot confirm without comparison images.The audible crack, persistent pain, and observed limb shortening with external rotation are consistent with a femoral stem fracture.Likely contributing factors: advanced age of 69-year-old, prior history of severe osteoarthritis, implant had been in place for 9 years, increasing risk of fatigue failure, stress shielding, and the femoral neck stump resection during primary surgery increased the stress on the implant.Therefore, there is no clinical indication that the reported adverse event was due to a malperformance of the implant or an implant failure.The impact to the patient was beyond the revision cannot be determined since the patient¿s outcome is unknown.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to non-device related factors.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or 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 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a thr surgery had been performed on (b)(6) 2016, the patient wanted to put on his pants and heard a crack in his right hip, which was the fracture of the polarstem stem std ti/ha 6 non-cem.Since then, he has been experiencing pain in his right hip.This adverse event was solved by a revision surgery on (b)(6)2025, in which the implants were revised.Current health status of patient is unknown.

• Brand Name: POLARSTEM STEM STD TI/HA 6 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23485856
• Report Number: 9613369-2025-00142
• Device Sequence Number: 13319058
• Product Code: LWJ
• UDI-Device Identifier: 07611996118605
• UDI-Public: 7611996118605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2025

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: 11/12/2021
• Device Catalogue Number: 75100469
• Device Lot Number: A1415375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71331860/LOT: 14MM04909; PN: 71332760/LOT: 14FM15211; PN: 71336500/LOT: 15LM15068
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG