TANDEM 71324046Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010494375), received between Jan 14, 2020 and May 1, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K023743, K211176, K231448); 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.

Recalls naming this device

1. Oct 15, 2024Open, Classified

   The Bipolar assembly contains an oversized Retainer Ring.

   Z-0326-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER AN UKA SURGERY PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED SYMPTOMS OF PROSTHETIC DISLOCATION, AND AN X-RAY REVEALED DETACHMENT OF THE BIPOLAR CUP FROM THE STEM AND THE HEAD. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH IT WAS NOTICED THAT THE IMPLANTS WERE NOT BROKEN, THAT THEY HAD BEEN CORRECTLY ASSEMBLED INITIALLY, AND THAT THEY HAD BECOME DETACHED, WITH THE DOME AND RING STILL ATTACHED AND THE HEAD STILL ATTACHED TO THE STEM. THE NEW JOINT REMAINED STABLE AFTER THE NEW COMPONENTS WERE PLACED.

  Patient problems: Joint Dislocation

  MAUDE report 25061998 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem; Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, ON (B)(6) 2024, THE PATIENT CAME IN FOR A HEMIARTHROPLASTY WHERE A TANDEM INTL BIPOLAR 46OD 28ID WAS IMPLANTED WITHOUT COMPLICATIONS. ON (B)(6) 2025 THE PATIENT REPORTED TO ED AND IT WAS FOUND THAT THE IMPLANTED BIPOLAR HAD DISASSOCIATED. THE PATIENT'S IMPLANT DISASSOCIATED IMPACTING THEIR MOBILITY AND INCREASING THEIR PAIN. THE PATIENT WAS BROUGHT IN FOR A REVISION SURGERY ON (B)(6) 2025. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 21217814 ↗
• MalfunctionOct 18, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A LEFT HIP HEMIARTHROPLASTY PERFORMED DUE TO MEDIAL DISLOCATED FEMORAL NECK FRACTURE, IT BECAME APPARENT THAT THE CONNECTION OF A TANDEM INTL BIPOLAR 46OD 28ID; BETWEEN THE INLAY AND THE RING WAS INADEQUATE. THE INLAY WOULD COME LOOSE AT THE SLIGHTEST TOUCH/TWIST, AND THE METAL RING DID NOT CLOSE AS USUAL (APPARENTLY TOO LARGE). THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SIZE 44 TANDEM WITH A 28 XS HEAD. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487471 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, SEVEN DAYS AFTERWARDS THE PATIENT EXPERIENCED A DISLOCATION DURING TRACTION REHABILITATION TRAINING. IT IS UNKNOWN HOW THIS EVENT WAS SOLVED OR TREATED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16731825 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PARTIAL ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021 TO REPAIR A FEMUR FRACTURE, THE PATIENT HAD TWO CONSECUTIVE FALLS AFTERWARDS, WHICH CAUSED TEARS IN ALL SOFT TISSUE SUPPORT STRUCTURES AROUND THE HIP JOINT. REDAPT SLVLS MONO STEM 240MM SZ 17 SO, COCR 12/14 FEM HEAD 28 +0 AND TANDEM INTL BIPOLAR 46OD 28ID WERE EXPLANTED. THE PATIENT WAS LEFT WITH A GURDLE STONE HIP. THE PATIENT CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Rupture

  MAUDE report 13089690 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED WITH A TANDEM SYSTEM ON (B)(6) 2021 TO TREAT A FEMUR FRACTURE, THE PATIENT SUFFERED FROM A HIP DISLOCATION SIX DAYS AFTERWARDS. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS ADDRESSED AND SO IS THE PATIENT CURRENT STATUS OF HEALTH.

  Patient problems: Joint Dislocation

  MAUDE report 11991459 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR A FEMORAL NECK FRACTURE AND UNDERWENT ARTIFICIAL FEMORAL HEAD REPLACEMENT USING THIS HEMI HIP PROSTHESIS COMPONENT (PRIMARY SURGERY). POSTOPERATIVELY, ON (B)(6) 2020, THE PATIENT DEVELOPED SYMPTOMS OF INFECTION SUCH AS WOUND REDNESS AND SWELLING WITH FLUID EXUDATION. TREATMENT: IMMEDIATE DEBRIDEMENT, LOCAL IODOPHOR AND SALINE IRRIGATION WERE GIVEN, AND THE ABOVE SYMPTOMS GRADUALLY IMPROVED AND DISAPPEARED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11123104 ↗
• InjuryDec 6, 2020Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A THR EVERYTHING WAS GOING NORMAL AND DR. DECIDED TO POSITION THE 46MM CUP (REF: (B)(4) LOT: R2008440) AND HEAD 28MM +4 (REF: (B)(4)) BUT POLYETHYLENE RING DID NOT FIT CORRECTLY AND SURGEON DECIDED TO IMPACT IT. DURING THE IMPACTION, A SMALL PIECE IN THE RING DAMAGED. NO BACKUP DEVICE WAS AVAILABLE AND ITEM WAS LEFT DAMAGED INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10955865 ↗
• InjuryJan 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED SINCE THE HEAD WAS OUT OF THE BIPOLAR BALL HEAD ONE DAY AFTER PRIMARY SURGERY. PATIENT WAS IN GOOD CONDITION.

  Patient problems: Injury

  MAUDE report 9586278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743, K211176, K231448. One submission often covers many models, so check the product and lot details in each record.

• Z-0350-2017 · Aug 29, 2016 · Terminated
  TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,
• Z-0351-2017 · Aug 29, 2016 · Terminated
  TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132