SL-PLUS 75002705Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611996078688), received between Mar 1, 2022 and Oct 7, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 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) 2008 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL CALCAR CRACK AND A SHAFT FRACTURE. THE PRECISE MOMENT IN SURGERY DURING WHICH THESE EVENTS 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: Bone Fracture(s)

  MAUDE report 15563821 ↗
• 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) 2004 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A CALCAR CRACK. 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 NOT KNOWN. 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 15555772 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE IN AN UNSPECIFIED REGION ASSOCIATED TO THE STEM PROSTHESIS. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2018 TO EXPLANT THE CUP, LINER, HEAD AND STEM. PATIENT 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: Bone Fracture(s)

  MAUDE report 14134327 ↗
• InjuryApr 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM PROSTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2009 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL STEM WAS EXPLANTED. 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 14131574 ↗
• InjuryMar 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2001, THE PATIENT SUFFERED A SPRAINED TRAUMA ON (B)(6) 2022. A CRACKING NOISE WAS HEARD, PAIN WAS FELT, AND MOVEMENT WAS RESTRICTED EVER SINCE. THE PATIENT PRESENTED TO THE HOSPITAL, AND IT WAS DETERMINED THAT THE SL-PLUS STANDARD STEM 6 NON-CEMENTED FRACTURED AT THE NECK. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT STEM. THE SURGEON ALSO MADE THE DECISION TO EXPLANT THE REST OF THE SYSTEM. PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 13636277 ↗

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.