MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CS-PLUS STANDARD STEM 4 CEMENTED; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75002278

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tha had been performed on (b)(6) 2012 with a cs-plus standard stem 4 cemented, it fractured under the neck on (b)(6) 2023, following a fall, as subsequently confirmed via x-rays.A revision surgery was performed on (b)(6) 2023, to exchange both stem and head.Patient is doing well on recovery.

Manufacturer Narrative

Additional information: d10 (concomitant devices added), h6 (component code, type of investigation, investigation findings, investigation conclusions), h8 (initial use of the device).Results of investigation: it was reported that, after a total hip arthroplasty had been performed on (b)(6) 2012 with a cs-plus standard stem 4 cemented, it fractured under the neck on (b)(6) 2023 following a fall, as subsequently confirmed via x-rays.A revision surgery was performed on (b)(6) 2023 to exchange both stem and head.The device used in treatment was not returned for investigation.A visual evaluation was performed on images contained in the medical report, and it showed that the cs-plus standard stem 4 cemented is fractured near the neck.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 (lit.No.12.23, ed 03/21) states "implant component fracture" as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.Based on the information provided, the clinical root cause of the stem fracture and subsequent revision was likely the patient¿s fall and is not associated with a mal-performance of the implant.The osteolytic changes around the stem could indicate micromotion was possible which could lead to fatigue fracture but cannot be confirmed.The patient impact beyond the revision cannot be determined.However it was reported that the patient is doing well on recovery.The root cause of the event can be attributed to the patient's fall, this is a known inherent risk of the implant under the specific circumstance of the fall.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Corrected data: e4 (reported did not send report to fda), h6 (health effect - clinical code).

Manufacturer Narrative

Corrected data: d9&h3 (device returned for analysis), e1 (contact name added), h6 (investigation conclusions, type of investigation).Updated results of investigation: it was reported that, after a total hip arthroplasty had been performed on (b)(6) 2012 with a cs-plus standard stem 4 cemented, it fractured under the neck on (b)(6) 2023 following a fall, as subsequently confirmed via x-rays.A revision surgery was performed on (b)(6) 2023 to exchange both stem and head.Two devices were completely returned for investigation (cs-plus stem (75002278) and ceramic ball head 32l (75004174)) were returned for investigation.The following complaint investigation tasks are related to the cs-plus stem.A visual evaluation was performed and it was concluded that the stem is fractured proximally, close to the stem neck.Heavy scratches are visible, potentially originating from a forceps during stem removal.Additionally , signs of corrosion are visible.A material analysis was done over the fractured surface of the cs-plus standard stem 4 cemented.It was concluded that about 80% of the fracture surface show fatigue striations, indicating that the observed crack propagated by fatigue.No pores, inclusions, observable material irregularities and elemental inhomogeneities which could have initiated or enhanced the crack growth, could be observed on the fracture surface.No particular cause of fracture initiation could be determined.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 (lit.No.12.23, ed 03/21) states "implant component fracture" as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.A medical evaluation was performed.Based on the information provided, the clinical root cause of the stem fracture and subsequent revision was likely the patient¿s fall and is not associated with a mal-performance of the implant.The osteolytic changes around the stem could indicate micromotion was possible which could lead to fatigue fracture but cannot be confirmed.The patient impact beyond the revision cannot be determined.However it was reported that the patient is doing well on recovery.Based on the performed investigation and provided information, the root cause of the reported event remains undetermined.However, the patient's fall is a known contributing factor for the alleged event due to the mechanical forces exerted on the stem with said fall impaction.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.The need for further actions is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned devices will be retained.

• Brand Name: CS-PLUS STANDARD STEM 4 CEMENTED
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 16931780
• MDR Text Key: 315220997
• Report Number: 9613369-2023-00147
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2018
• Device Catalogue Number: 75002278
• Device Lot Number: B1139701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/09/2023; 01/12/2024
• Supplement Dates FDA Received: 06/12/2023; 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 75003893 / LOT: C1140480; PN: 75004007 / LOT: B1141420; PN: 75004174 / LOT: C1140490
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male