MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

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

Patient Problem Subluxation (4525)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

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", following a tha index procedure in which a ep-fit plus and a sl-plus were implanted as the acetabular and femoral components respectively, ten (10) patients experienced a postoperative subluxation.The measures taken to treat these instances were not provided within the publication.Additional details regarding the clinical course of these patients were also not provided.No further information is available.

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, ten (10) patients experienced a postoperative subluxation.The measures taken to treat these instances were not provided within the publication.The complaint devices, used in treatment, were not received for investigation and a visual inspection could not be performed.The exact part and batch number of the devices 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 devices at the time of distribution.However, a review of the 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.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.Should any additional clinical information be provided, this complaint will be re-evaluated.[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: UNKN. EP-FIT PLUS SHELL
• 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: 15601635
• MDR Text Key: 301725150
• Report Number: 9613369-2022-00572
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention