SMF 71352703Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556159248), received between Mar 8, 2018 and May 10, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K123012, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT WAS SEEN BY HIS SURGEON WHO NOTICED THAT HE CONTINUED TO HAVE SOME OCCASIONAL PAIN, AS WELL AS, A LIMP WITH WEAKNESS ON HIS LEFT SIDE. SURGEON STATED HIS LIMP WILL NOT CHANGE AS HE HAS PERMANENT MUSCLE DAMAGE. A REPEAT MRI PERFORMED ON (B)(6) 2018 REVEALED ANOTHER FLUID COLLECTION AND HIS CRP AND ESR WERE BOTH ELEVATED. A SUBSEQUENT LARGE ASPIRATION WAS FOUND TO HAVE INCREASED WHITE BLOOD CELLS. IT WAS DETERMINED HE WAS SUFFERING FROM AN INFECTION AND WOULD REQUIRE A TWO-STAGE REVISION SURGERY. ON (B)(6) 2018 PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY RESECTION AND PLACEMENT OF AN ANTIBIOTIC SPACER. INTRAOPERATIVELY, IT WAS CLEAR THAT PATIENT HAD SEVERE INFECTION THROUGHOUT THE HIP. THERE WAS FURTHER NECROSIS AND DAMAGE TO THE SOFT TISSUES. THE ENTIRE PSEUDOCAPSULE POSTERIORLY WAS REMOVED AS THERE WAS ABNORMAL TISSUE THROUGHOUT. THERE WAS A VERY LARGE AREA OF INFECTED TISSUE THROUGHOUT THE TROCHANTER, HIS ENTIRE POSTERIOR ASPECT OF HIS TROCHANTER LEAVING ONLY PROBABLY ABOUT 50% OF THE ANTERIOR ABDUCTOR STILL CONNECTED. THE REST OF THE POSTERIOR TROCHANTER WAS BOG. A PICC LINE WAS INSERTED AND 6 WEEKS OF IV ANTIBIOTICS WAS RECOMME

  Patient problems: Unspecified Infection

  MAUDE report 8600797 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER REVISION SURGERY ON (B)(6) 2017, PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2017 DUE TO THE DRAINAGE HE WAS EXPERIENCING FROM HIS INCISION ERUPTED THE DAY BEFORE. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE, SYNOVECTOMY, AND THE PLACEMENT OF ANTIBIOTIC ABSORBABLE BEADS. SURGEON FOUND THAT THERE WAS NECROTIC TISSUE ONLY AT THE AREA OF DRAINAGE AND THE REST OF THE INCISION LOOKED GOOD. UPON ENTERING THE POSTERIOR CAPSULE, IT WAS CLEAR THAT THE POSTERIOR CAPSULE REPAIR HAD NOT HEALED AT ALL, AND THIS, AGAIN LOOKED LIKE NECROTIC TISSUE, AS WELL AS NECROTIC BONE. SURGEON PERFORMED FURTHER DEBRIDEMENT OF THE NECROTIC TISSUE, BUT DID HAVE TO LEAVE SOME POSTERIOR NECROTIC TISSUE AS IT WAS ADHERENT TO THE SCIATIC NERVE. THE CULTURES FOR THIS SURGERY WERE NEGATIVE.

  Patient problems: Injury

  MAUDE report 8600783 ↗
• InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY WAS PERFORMED DUE TO POSTOPERATIVE BONE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8233615 ↗
• InjurySep 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING. THE STEM, THE LINER AND THE FEMORAL HEAD WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7840923 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE SMF.

  Patient problems: Injury

  MAUDE report 7338483 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 7323395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123012, 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.