MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924)

Event Date 06/11/2002

Event Type  Injury  

Event Description

It was reported that, on the literature review "short-term results with the zweymueller-sl metal-on-metal total hip arthroplasty", a total of 266 patients underwent an index surgery where a bicon plus shell and a sl-plus stem were implanted as part of a total hip replacement procedure.Four (4) patients experienced septic loosening of the stem due to a staphylococcus aureus infection.These patients underwent a revision surgery 5, 12, 13 and 48 months post-operatively.Further information is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).Korovessis, p., petsinis, g., repanti, m., papazisis, z., iliopoulos, p., & soucacos, p.N.(2002).Short-term results with the zweymueller-sl metal-on-metal total hip arthroplasty.European journal of orthopaedic surgery & traumatology, 12(2), 81-89.

Manufacturer Narrative

H6, new health effect - clinical code was added.H3, h6: in the study of korovessis, p., et.Al.[1], a total of 266 patients underwent an index surgery where a bicon plus shell and a sl-plus stem were implanted as part of a total hip replacement procedure.Four (4) patients experienced septic loosening of the stem due to a staphylococcus aureus infection.These patients underwent a revision surgery 5, 12, 13 and 48 months post-operatively.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, the instructions for use states loosening of implant for the component as a ¿potential medical device problems¿ and also states infection as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.A review of the risk management documentation verifies the failure mode 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.

• Brand Name: SL-PLUS STEM
• Type of Device: 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: 15404023
• MDR Text Key: 299748264
• Report Number: 9613369-2022-00494
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/20/2022
• 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
• Treatment: UNKN. BICON-PLUS SHELL
• Patient Outcome(s): Hospitalization; Required Intervention