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

Model Number	75100464
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced breakage of the polarstem stem std ti/ha 1 non-cem.This adverse event was treated by a revision surgery on (b)(6) 2023, in which the polarstem stem std ti / ha 1 non-cem was exchanged.Patient's current health status is in a good general condition.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h10: it was reported that, after a revision total hip replacement surgery, the patient experienced breakage of the polarstem stem std ti/ha 1 non-cem.This adverse event was treated by a revision surgery in which a polarstem stem std ti/ha 1 non-cem was exchanged.Patient's current health status is in a good general condition.The complaint device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the stem is fractured on the distal side.The area around the proximal thread appears to be fine but heavy scratches can be seen around the fracture area.It is suspected, that the scratches arose while removing the implant from the body.An assessment of the material properties was conducted and it was concluded that about three quarter of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue.Crack initiation was found to be at the lateral side of the fractured stem in the distal region.The residual fracture surface showed characteristic of ductile overload.No pores or inclusions, which could have initiated or enhanced crack growth, could be observed on the fracture surface.In the area of assumed crack initiation, no scratches have been found but could be hidden under the coating.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 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 states "implant component fracture" as a ¿potential medical device problems¿, and "overweight patient, obesity" is also indicated as a "risk factor" which can influence the success of the operation resulting from a hip arthroplasty.With the limited information provided, the clinical root cause of the pain and loosening polar shaft cannot be definitively concluded; however, the patients¿ very severe obesity cannot be ruled out as a possible contributing factor to her pain and clinical status.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.Specific factors known to contribute to the alleged event are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight and trauma to the joint replacement.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.Internal complaint reference number: (b)(4).

• Brand Name: POLARSTEM STEM STD TI/HA 1 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17232612
• Report Number: 9613369-2023-00167
• Device Sequence Number: 15218196
• Product Code: LWJ
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 08/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B2018933
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 122 KG