TANDEMRecalls & reported problems across all models

We found 58 models of TANDEM by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 169 adverse event reports in the FDA's MAUDE database, received between May 17, 2017 and Jun 11, 2026 — classified as 84 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Break” (47 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TANDEM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 TANDEM problems

TANDEM models

58 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TANDEM 71324046

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall9 reports
• TANDEM 71362804

  Prosthesis, hip, femoral component, cemented, metal
  18 reports
• TANDEM 71362803

  Prosthesis, hip, femoral component, cemented, metal
  10 reports
• TANDEM 71367900

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  9 reports
• TANDEM 71322046

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  8 reports
• TANDEM 71363045

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  6 reports
• TANDEM 71324044

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  6 reports
• Tandem 71326600

  Prosthesis, hip, hemi-, femoral, metal ball
  5 reports
• TANDEM 71363047

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  5 reports
• TANDEM 71367903

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  5 reports
• TANDEM 71324045

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  5 reports
• TANDEM 71363046

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  4 reports
• TANDEM 71367908

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  4 reports
• TANDEM 71324050

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  4 reports
• TANDEM 71363044

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• TANDEM 71363052

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• TANDEM 71363053

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• TANDEM 71322042

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• TANDEM 71322049

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• TANDEM 71324048

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• Tandem 126643

  Prosthesis, hip, hemi-, femoral, metal ball
  2 reports
• Tandem 126651

  Prosthesis, hip, hemi-, femoral, metal ball
  2 reports
• Tandem 71326604

  Prosthesis, hip, hemi-, femoral, metal ball
  2 reports
• TANDEM 71363042

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71363049

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71363050

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71363057

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71367904

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71367912

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• TANDEM 71322044

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• TANDEM 71322045

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• TANDEM 71322051

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• TANDEM 71322052

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• TANDEM 71324040

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• TANDEM 71324054

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• Tandem 126645

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 126646

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 126648

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 126649

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 126650

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 126654

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• Tandem 71326603

  Prosthesis, hip, hemi-, femoral, metal ball
  1 report
• TANDEM 71363043

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• TANDEM 71363048

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• TANDEM 71363051

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• TANDEM 71363054

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• TANDEM 71322043

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71322047

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71322050

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71322053

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71322055

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71322057

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324043

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324047

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324049

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324052

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324055

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• TANDEM 71324038

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report

Recent TANDEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Fracture

  IT WAS REPORTED THAT, DURING A PHA SURGERY, ONE (1) TANDEM TRIAL SHELL HANDLE WAS BROKEN WHILE TRIALING THE BIPOLAR HEAD .THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470584 ↗
• 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 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE POLARSTEM STEM STANDARD 2 CEMENTED, THE TANDEM INTL BIPOLAR 52OD 28ID AND THE OXONIUM FEM HD 12/14 28MM +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS ALSO UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23666016 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HEMIARTHROPLASTY THAT HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A TANDEM INTL BIPOLAR 43OD 28ID WAS EXPLANTED AND PERFORMED A TOTAL THR WITH A STRYKER ACETABULAR COMPONENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22895440 ↗
• InjuryAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THE SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED DISLOCATION AFTER FALLING FROM BED AND A CLOSED REDUCTION WAS ATTEMPTED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE TANDEM BIPOLAR COCR 46OD 28ID WAS REMOVED AND IT WAS NOTICED THAT THE 28MM HEAD WAS STILL ATTACHED TO THE STEM AND THE TANDEM BIPOLAR LOCKING RING WAS INTACT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22784853 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025 , THE PATIENT FELL OVER AND THE HIP DISLOCATED. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) TANDEM INTL BIPOLAR 48OD 28ID AND ONE (1) COCR 12/14 FEM HEAD 28 +0 WERE EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 22356637 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY WHILE INSERTING THE CUP, THE HANDLE OF ONE (1) TANDEM TRIAL SHELL HANDLE BROKE IN HALF. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400767 ↗
• 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 ↗
• InjuryDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY, IT WAS NOTICED THAT THE COCR 12/14 FEM HEAD 28 + 4 STAYED ON THE STEM AND THE TANDEM BIPOLAR COCR 44OD 28ID DISSOCIATED AND IS FLOATING IN THE HIP JOINT. THE PATIENT IS BEING REFERRED OUT TO ANOTHER SURGEON TO PERFORM THE REVISION (EXPECTED ON (B)(6) 2024) LIKELY TO A DUAL MOBILITY OR CONSTRAINED LINER AFTER AN ACETABULAR SHELL IS IMPLANTED. / THEY WILL NEED A REVISION SURGERY TO REMOVE THE SHELL AND HAVE AN ACETABULAR SHELL PLACED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21047106 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) TANDEM TRIAL SHELL HANDLE SNAPPED IN HALF DURING USE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552869 ↗
• 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 ↗
• InjurySep 19, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A THA REVISION PERFORMED DUE TO AN INFECTION, THE INITIAL PLAN WAS TO RETAIN THE EXISTING CUP AND STEM WHILE REPLACING THE FEMORAL HEAD WITH AN OR3O IMPLANT. THE EXISTING COMPONENTS INCLUDED A METAL R3 LINER, 58 MM SHELL AND A HEMI HEAD 46MM. ALTHOUGH THE FEMORAL HEAD WAS SUCCESSFULLY REMOVED, THE SLEEVE REMAINED LODGED ON THE NECK-TRUNNION. THE SURGEON REQUESTED A TANDEM UNIPOLAR 46MM FOR THE REPLACEMENT; HOWEVER, HE WAS ADVISED THAT USING A UNIPOLAR HEAD WITH THIS CONSTRUCT WAS OFF-LABEL. BASED ON THE SIZE OF THE SHELL (58 MM) AND THAT THE SLEEVE WAS STUCK, THE RECOMMENDATION WAS TO REMOVE THE METAL R3 LINER, REPLACING IT WITH A XLPE R3 LINER, AND USING A 40 MM OXINIUM HEAD, AS THE UNIPOLAR HEAD WAS NOT SUITABLE FOR THE R3 METAL-ON-METAL CONSTRUCT. DESPITE HAVING MULTIPLE OPTIONS AVAILABLE IN THE OR AND BEING AWARE THAT IT WAS AN OFF-LABEL USE, THE SURGEON DECIDED TO PROCEED WITH THE TANDEM UNIPOLAR 46MM. THE HEAD WAS IMPACTED AND THE HIP WAS REDUCED. THE SURGEON REVIEWED THE X-RAYS AND WAS SATISFIED WITH THE RESULT. IT WAS MENTIONED THAT THE PATIENT WAS IN BAD SHAPE AND WOULD LIKELY BE REVISED SOON. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260053 ↗
• MalfunctionJul 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR, THE THREADS ON A TANDEM STR THREADED HNDLE WERE BROKEN, THEREFORE THE TRIALS WON'T SCREW ON. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861293 ↗
• InjuryJul 3, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISLOCATION APPROXIMATELY SIX WEEKS LATER. TO ADDRESS THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE, DURING WHICH ONE (1) TANDEM INTL BIPOLAR 55OD 28ID WAS EXCHANGED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19671927 ↗
• MalfunctionMay 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE TANDEM TRIAL SHELL HANDLE BROKE. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400795 ↗

Other Smith & Nephew, Inc. products

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