SL-PLUS 75002697Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611996078640), received between Sep 3, 2019 and Oct 7, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 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) 2007 TO ADDRESS AVASCULAR NECROSIS AND OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL SHAFT PENETRATION. 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: Perforation

  MAUDE report 15560519 ↗
• InjuryApr 18, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON  (B)(6) 2009, THE STEM WAS LOOSENED AND THE CUP WAS MISALIGNED. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON  (B)(6) 2017 TO EXPLANT THE CUP, LINER, 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 (B)(6) 2021.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 14134548 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE ALL DEVICES 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.

  Patient problems: Joint Dislocation

  MAUDE report 14132940 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, EXCHANGING LINER, CUP AND HEAD DUE TO LOOSENING OF THE CUP. DURING THE PROCEDURE, THE STEM HAD TO BE EXPLANTED SINCE THE HEAD WAS COMPLETELY STUCK ON THE STEM. THIS WAS NOT PLANNED AND THERE WAS ONE HOUR DELAY.

  Patient problems: Injury

  MAUDE report 9659822 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF THE PLUS SL STD STEM 2 WAS PERFORMED DUE TO RIGHT HIP ARTHROPLASTY PERIPROSTHESIS FRACTURE, CONFIRMED UNDER X-RAYS.

  Patient problems: Hip Fracture

  MAUDE report 8956956 ↗

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.