MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 4 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	75002701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a thr performed, an unknown.Sl-plus stem broke.It is unknown when and where the implantation was performed or if a revision surgery is planned.Current status of patient is unknown.
Event or Problem Description
It was reported that, after a thr performed on (b)(6)2019, a sl-plus standard stem 4 non-cemented broke.A revision surgery took place (b)(6), where an slr stem was implanted.The patient has been discharged from the hospital.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5, h6¿.
Additional Manufacturer Narrative
D1, d2a, d2b, d4, g4, h3, h6: the device was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.Further, the respective product specifications have been reviewed without the detection of any indications contributing to the reported failure.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 a 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.A review of the device labeling revealed that the ifu (lit.No.12.23, ed.03/21) states implant component fracture of the component as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.Without the requested supporting clinical documentation, the pre/post implantation radiographic imaging or the return of the device, the definitive clinical cause of the reported adverse event could not be determined.The ifu for the sl plus standard stem 4 non-cemented 81098833 0, does list ¿overweight patient, obesity (bmi >30),¿ under risk factors that can influence the success of the operation.Therefore, we cannot rule out the implantation selection and positioning, the patient's weight of > 100kg, bone quality, and a potential trauma and/or fall as likely contributing factors.Since it was reported the patient was discharged from the hospital without further complications, the impact to the patient was the revision and the expected post-operative convalescent period.The performed investigation does not lead to an accurately determined cause.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.Smith+nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: SL-PLUS STANDARD STEM 4 NON-CEMENTED
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 20775811
• Report Number: 9613369-2024-00149
• Device Sequence Number: 4400044
• Product Code: KWY
• UDI-Device Identifier: 07611996078664
• UDI-Public: 7611996078664
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2026
• Device Catalogue Number: 75002701
• Device Lot Number: H1900895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/27/2024; Not provided
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown