SL-PLUS 75002701Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996078664), received between Nov 22, 2019 and Nov 25, 2024 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K072852, K211176); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Fracture; Fracture

  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.

  Patient problems: Failure of Implant

  MAUDE report 20775811 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2006 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL TROCHANTERIC FRACTURE. THE PRECISE MOMENT IN SURGERY DURING WHICH THIS EVENT TOOK PLACE IS NOT CLEAR, NOR ARE THE MEASURES TAKEN TO RESOLVE THIS COMPLICATION. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A BICON-PLUS SHELL AND THAT SUSTAINED AN INTRAOPERATIVE ADVERSE EVENT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 15556396 ↗
• InjuryApr 18, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A LOOSENING OF THE STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE THE STEM AND THE HEAD WERE EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14134564 ↗
• InjuryApr 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL STEM AND HEAD PROSTHESIS WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED STEM. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14087729 ↗
• DeathApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL THR SURGERY PERFORMED (ONLY ONE IS FROM SMITH AND NEPHEW) ON (B)(6) 2010, THE CLINICAL SUBJECT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 14074503 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND FRACTURE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12267408 ↗
• InjuryFeb 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE SL-PLUS STANDARD STEM 4 NON-CEMENTED FRACTURED. THE PATIENT HAS HISTORY OF MULTIPLE PREVIOUS OPERATIONS. IT IS UNKNOWN WHETHER THE STEM HAS BEEN REVISED TO THIS DATE OR NOT. THE CURRENT STATUS IN THE PATIENT'S HEALTH IS ALSO UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11284667 ↗
• InjuryNov 22, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN STEM'S NECK. THIS WAS NOTICED UPON X-RAYS AFTER THE PATIENT WAS RECEIVED IN THE HOSPITAL WITH PAIN.

  Patient problems: Injury

  MAUDE report 9365367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072852, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.