SL-PLUS 75002703Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996078671), received between Apr 11, 2022 and Apr 18, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION, A PERI-PROSTHETIC FRACTURE AND LOOSENING OF THE SL-PLUS STANDARD STEM 5 NON-CEMENTED. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2008 TO EXPLANT 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); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14134435 ↗
• InjuryApr 17, 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) 2010, THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2012 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL IMPLANTS WERE 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 (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 14132166 ↗
• InjuryApr 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEAM AND WEAR OF THE ACETABULAR COMPONENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL COMPONENTS FROM THE THA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14131601 ↗
• InjuryApr 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM AND ACETABULAR CUP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL COMPONENTS OF THE RIGHT THA HIP CONSTRUCT WERE EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021. FURTHER INFORMATION WILL NOT BECOME AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14131567 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL COMPONENTS FROM THE THA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED CONSTRUCT. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021. FURTHER INFORMATION WILL NOT BECOME AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14121457 ↗
• InjuryApr 12, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM AND A JOINT DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE THA PROSTHESIS CONSTRUCT WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 14079994 ↗
• InjuryApr 11, 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) 2015, THE PATIENT SUFFERED A PERI-PROSTHETIC FRACTURE ON THE SL-PLUS STANDARD STEM 5 NON-CEMENTED. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015 TO EXPLANT HEAD AND STEM. PATIENT 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. INSPECTION OF THE DATA SHOWS THAT THE CALCULATED PTIR (REVISION RATE PER ONE HUNDRED PATIENT YEARS OF IMPLANTATION) OF BICON-PLUS IS ABOVE THE AVERAGE 071 (0.57-0.88) FOR THEIR GROUP PTIR¿S 0.38. FURTHER INFORMATION WILL NOT BECOME AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14079754 ↗

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.