MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM LATERAL 1 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	75001951
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Discomfort (2330); Aseptic loosening (4883)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively 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 surgery had been performed on (b)(6) 2012, the patient experienced a feeling of wrongness and loosening of one (1) slr-plus revision stem lateral 1 non-cem.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the stem, head and liner were removed and s+n product were implanted.Current health status of patient remains unknown.
Additional Manufacturer Narrative
H3, h6: the complaint device used in treatment was returned for investigation.A visual evaluation of the returned part was conducted, and it was concluded that no parts are missing or have been broken-off.The device is showing slight signs of usage around the cone.This potentially comes from device explantation.Otherwise it has no irregularities.Furthermore, only slight signs of osteointegration are visible in the zoomed view.The two returned concomitant devices were also visually analyzed.The ball head device is scuffed on the edge of the outer rim.The liner is significantly worn and slightly discolored.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.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 a similar 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.The instructions for use (81116546 rev 0) states osseointegration problem as a ¿potential medical device problems¿ and discomfort as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.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.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.
Event or Problem Description
It was reported that, after a thr surgery had been performed on (b)(6) 2012, the patient experienced a feeling of wrongness and loosening of one (1) sl-plus mia stem lateral 1 non-cem.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the stem, head and liner were removed and s+n product were implanted.Current health status of patient remains unknown.

• Brand Name: SL-PLUS MIA STEM LATERAL 1 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: 22024997
• Report Number: 9613369-2025-00090
• Device Sequence Number: 15216705
• Product Code: KWY
• UDI-Device Identifier: 07611996079630
• UDI-Public: 07611996079630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2019
• Device Catalogue Number: 75001951
• Device Lot Number: A1143881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided; 07/31/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/25/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2012
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71333373 / LOT: UNKNOWN.; PN: 71336448 / LOT: UNKNOWN.; PN: 71342800 / LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown