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

Catalog Number	75001954
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Periprosthetic fracture (4902)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed on an unknown date, the patient made a rotational movement in the left hip and experience a marked "cracking" followed by sudden severe pain on (b)(6) 2026.In addition, patient fell to the right side of the body.It is unknown how this adverse event has been addressed.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: additional information: a2, b1, b2, b5, b7, h6: health effect - clinical and impact code, medical device problem code.
Event or Problem Description
It was reported that after a thr was performed in 2023, the patient made a rotational movement of the left hip and experienced a marked ¿cracking¿, followed by sudden severe pain and loss of strength on (b)(6) 2026.In addition, the patient fell onto the right side of the body.The event was addressed with a revision surgery performed on (b)(6) 2026, during which the sl-plus mia stem lateral 4 non-cemented implant was explanted.Pre-revision x-rays were reviewed and showed a fracture at the neck of the stem.Post-revision images showed what appeared to be a femoral fracture.It is unknown whether this was associated with the stem fracture or resulted from the revision procedure.The patient¿s current health status is unknown.

• Brand Name: SL-PLUS MIA STEM LATERAL 4 NON-CEM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24349569
• Report Number: 9613369-2026-00012
• Device Sequence Number: 9986999
• Product Code: KWY
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2026

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 Catalogue Number: 75001954
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/07/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male