SL-PLUS/INTEGRATION-PLUS 75000189Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996092912), received between Aug 14, 2020 and Apr 24, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K122296, K143096, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, IT WAS FOUND THAT THE INCORRECT STEM WAS IMPLANTED. THE SL-PLUS INTEGR MIA STEM WITH TI/HA 4 HAD BEEN PLANNED TO BE IMPLANTED, BUT A SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 4 WAS OPENED AND IMPLANTED INSTEAD. THERE IS NO HEALTH HARM TO THE PATIENT AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19177421 ↗
• InjuryAug 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED TO PAIN, BONE FRACTURE AND LOOSENING OF THE STEM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 4 WAS EXCHANGED TO A COMPETITOR STEM (VERSYS CRC). PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 17538080 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY THR CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S LEFT HIP, THE PATIENT HAS BEEN SUFFERING FROM PAIN, UNEQUAL LIMB LENGTH AND, RADIOLOGICALLY, A SINTERING OF THE STEM APPEARS IN COMPARISON TO THE PRELIMINARY RECORDED X-RAYS. A POTENTIAL REVISION SURGERY WAS MENTIONED IN CASE OF INCREASING PAIN, HOWEVER IT WAS NOT CONFIRMED. PRIMARY IMPLANTATION OF SL-MIA STEM, BIOLOX DELTA BALL HEAD (SN) AND ALLOFIT CUP, DURASUL INSERT (ZIMMER) WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Injury; Pain; Unequal Limb Length

  MAUDE report 10408340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122296, K143096, 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.