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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported that, on the literature review "mid-term results with the enhanced pressfit (epf) cup in osteoarthritis, chronic polyarthritis, and revision arthroplasty", during a tha index procedure in which a ep-fit plus and a sl-plus were implanted as the acetabular and femoral components respectively, thirteen (13) patients experienced an intraoperative fracture.Twelve (12) of them were associated to the trochanteric region and the remaining patient (1) sustained a diaphyseal fracture.Additional details regarding the measures taken to resolve all instances were not provided within the publication.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Mid-term results with the enhanced pressfit (epf) cup in osteoarthritis, chronic polyarthritis, and revision arthroplasty.

Manufacturer Narrative

H3, h6: in the literature review "mid-term results with the enhanced pressfit (epf) cup in osteoarthritis, chronic polyarthritis, and revision arthroplasty" [1], following a total hip arthroplasty index procedure in which a ep-fit plus and a sl-plus were implanted as the acetabular and femoral components respectively, thirteen (13) patients experienced an intraoperative fracture.Twelve (12) of them were associated to the trochanteric region and the remaining patient (1) sustained a diaphyseal fracture.The complaint device, used in treatment, was not received for investigation and a visual inspection could not be performed.The exact part and batch number of the device is not known.Therefore, the batch record review could not be performed and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, insufficient information was made available to determine the revision of instructions for use applicable to the device at the time of distribution.However, a review of current revision was conducted and the instructions for use lists several possible adverse effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the performed investigations, a relationship between the reported devices and the reported incidents cannot be excluded, but the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: doets hc, olsthoorn pgm, schmotzer h.Mittelfristige ergebnisse mit der enhanced pressfit (epf) pfanne bei arthrose, chronischer polyarthritis und bei der revisionsarthroplastik.In: pressfit pfannen (ed.: effenberger h, zichner l, richolt j) mcu 2004; 137- 142.Internal complaint reference (b)(4).

• Brand Name: SL-PLUS STEM
• 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: 15626235
• MDR Text Key: 301934334
• Report Number: 9613369-2022-00579
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization