MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 01 NON-CEMENTED; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75002716

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr had been performed on (b)(6) 2002 with a bicon-plus/sl-plus system, on (b)(6) 2023 the patient made a turning movement while shopping and felt a shooting pain in his left hip.X-rays taken on (b)(6) 2023 showed a fatigue fracture about 3 cm from the tip of the cementless straight sl-plus stem size 01/14.A revision surgery was performed on (b)(6) 2023 to address this event.Not only the stem, but also the ceramic head and the bicon liner were explanted, while the bicon shell was retained.The patient has been discharged, has good self-mobilization with full load on forearm crutches on station level and stairs.

Manufacturer Narrative

D4, d10.

Manufacturer Narrative

D4: part number and udi number updated.

Manufacturer Narrative

Results of investigation: it was reported that, after a total hip replacement had been performed with a bicon-plus/sl-plus system, the patient made a turning movement while shopping and felt a shooting pain in his left hip.X-rays taken showed a fatigue fracture about 3 cm from the tip of the cementless straight sl-plus stem size 01.A revision surgery was performed to address this event.Not only the stem, but also the ceramic head and the bicon liner were explanted, while the bicon shell was retained.The patient has been discharged, has good self-mobilization with full load on forearm crutches on station level and stairs.The device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the complaint sample shows a broken-off part at its distal end.An assessment of the material characteristics of the product was performed to evaluate the fracture, and the area of the assumed crack initiation could be identified through macroscopic analysis of fatigue striations.The area of the assumed crack origination overlaps with the laser marking on the distal area of the stem.The labelling drawing, valid during the time of production of the complaint sample, has been reviewed and confirms the position of the laser marking.The complaint history review for the complaint device revealed no additional complaints for the affected batch since launch, nor additional complaints for the same product number over the past 12 months with similar failure mode.An additional complaint history review from january 2014 until today for the alleged device has been performed on part family level (all sl-plus standard non-cemented stems).The review revealed no additional complaints for the part family with a similar failure as a fracture through the distal end.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) furthermore states "implant component fracture" as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.The available medical documents were reviewed.A review of the provided x-rays confirms the fracture of the stem.Based on the information provided, loosening around the femoral shaft was confirmed, explaining the reported pain and the subsequent revision.The patient has been reported to have good self-mobilization with full load on forearm crutches as of discharge.The broken tip of the initial stem was left within the femur as a ¿cement plug¿.Further effect of this broken piece is not likely as it¿s a contained implantable device, but this cannot be confirmed.Based on the available information and the performed investigation, the reported failure of the fractured stem at its distal end could be verified, but the cause of the reported failure could not be identified.However, this device has been implanted for 21 years; constant repetitive load during normal use and poor bone support from stress shielding due to the confirmed loosening of the stem around the femoral bone, as well as possible microcracks initiated at the laser marking due to mechanical stress, are known to be contributing factors for a fatigue fracture of the stem to occur.The observed failure mode is covered within the risks anticipated in the risk management documentation of the product.No further escalation is required.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.

• Brand Name: SL-PLUS STANDARD STEM 01 NON-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: 16889303
• MDR Text Key: 314774493
• Report Number: 9613369-2023-00144
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 07611996000535
• UDI-Public: 7611996000535
• 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,Followup
• Report Date: 10/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 75002716
• Device Lot Number: 920520.097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/16/2023; 05/16/2023; 10/11/2023
• Supplement Dates FDA Received: 05/16/2023; 06/30/2023; 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75003577/LOT: 01.4348; PN: 75004170/LOT: UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG