CS-PLUS/CSL-PLUS 75002165Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07611996056563), received between Jan 19, 2018 and May 5, 2026 — classified as 9 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A HIP REVISION SURGERY, ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 AND ONE (1) STEM IMPACTOR ROD FRACTURED DURING REMOVAL OF A PRIMARY STEM. THE FRACTURED COMPONENT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 25078622 ↗
• MalfunctionFeb 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF IN ONE (1) POLARSTEM EXTRACTOR BLOCK WHEN THE SURGEON WAS TRYING TO REMOVE THE STEM SINCE HE DECIDED TO USE A DIFFERENT IMPLANT SIZE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288359 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 BROKE WHILE ATTEMPTING TO EXTRACT THE IMPLANTED POLAR STEM. THE BROKEN PIECE WAS FULLY RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE 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 22669070 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE TIP OF A CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 BROKE OFF IN THE STEM. 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 21688197 ↗
• MalfunctionDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 SNAPPED DURING POLARSTEM REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024556 ↗
• MalfunctionSep 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE REVISION, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT SCREW M6 BROKE WHILE EXPLANTING THE FEMORAL COMPONENT, IT WAS COMPLETELY REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320534 ↗
• MalfunctionJul 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF AFTER REMOVING STEM. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749278 ↗
• InjurySep 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA REVISION SURGERY DUE TO AN INFECTION, WHILE ATTEMPTING TO EXPLANT AN UNKNOWN POLARSTEM, THE THREADS OF A CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE IN THE POLARSTEM. AN EXTENDED TROCHANTERIC OSTEOTOMY HAD TO BE PERFORMED TO REMOVE THE STEM. A WINQUIST REMOVAL SET WAS USED TO LOCK ONTO THE BROKEN THREADS BUT THE FIXATION WAS TOO STURDY TO PULL STEM OUT WITHOUT BREAKING THE TROCHANTER; IT IS CURRENTLY UNKNOWN HOW MUCH OF A DELAY THIS PROCESS CAUSED. ALL THE IMPLANTED COMPONENTS WERE EXPLANTED AND EXCHANGED FOR PROSTALAC IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation

  MAUDE report 17814201 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643114 ↗
• MalfunctionJul 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF WHEN THREADED ONTO THE PROXIMAL PART OF THE IMPLANT. FURTHERMORE, ALL PIECES WERE RECOVERED, HOWEVER NO X-RAYS ARE AVAILABLE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410914 ↗
• InjuryOct 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE THREADED INSERTER OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF WITHIN THE POLARSTEM THAT WAS MEANT TO BE REMOVED. THE FEMUR WAS CRACKED TO REMOVE THE STEM THAT CONTAINED THE FRACTURED PIECE. SURGERY WAS DELAYED LESS THAN 30 MIN AS A CONSEQUENCE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 15635203 ↗
• MalfunctionSep 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE ATTEMPTING TO EXTRACT THE STEM DURING A THR, THE CS/CSL/GERADSCHAFT-PLUS EXTRACT SCREW M6 BROKE OFF INTO THE POLARSTEM EXTRACTOR BLOCK. ALL BROKEN PIECES WERE EXTRACTED FROM PATIENT, AND WERE DISCARDED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337415 ↗
• MalfunctionAug 28, 2022Peeled/Delaminated; Deformation Due to Compressive Stress; Peeled/Delaminated; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING THE SET-UP FOR A THA SURGERY, A CS/CSL/GERADSCHAFT-PLUS EXTRACT SCREW M6 WAS CROSS THREADED INTO THE IMPLANT AND THE METAL IS BEGINNING TO PEEL OFF. AS THIS WAS NOTICED DURING THE SET-UP, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307975 ↗
• MalfunctionJun 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THR, THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 BROKE WHILE INSIDE THE PATIENT. THE SURGERY FINISHED WITH A COMPETITOR'S DEVICE. NO INJURY OR SIGNIFICANT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672459 ↗
• MalfunctionApr 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL HIP REPLACEMENT CASE, THE TIP OF A GERADSCHAFT-PLUS EXTRACTION SCREW M6 BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247410 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT A CS/CSL/GERADSCHAFT-PLUS EXTRACT SCREW M6 HAS A BROKEN THREAD. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667464 ↗
• MalfunctionNov 16, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS OF ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING INTERNAL OR EXTERNAL USE TO PATIENT AND IF THERE WAS A DELAY AS CONSEQUENCE OF THIS ALLEGATION; THEREFORE, IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Insufficient Information

  MAUDE report 12820149 ↗
• MalfunctionNov 16, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO (2) CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING INTERNAL OR EXTERNAL USE TO PATIENT AND IF THERE WAS A DELAY AS CONSEQUENCE OF THIS ALLEGATION; THEREFORE, IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Insufficient Information

  MAUDE report 12820132 ↗
• InjuryAug 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A HIP REVISION, THE THREADED SHAFT OF A CS/ CSL/ GERADSCHAFT-PLUS EXTRACT. SCREW M6 SHEARED OFF WITH PART OF THE STEM LEFT IN TO THE EXTRACTOR BLOCK (CONNECTED TO THE NECK OF THE POLAR STEM) AND THE REMAINING PART LEFT IN THE SURGEON'S HAND. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268475 ↗
• InjuryAug 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING THR, CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 SHEARED OFF WHILE IT WAS BEING SCREWED INTO THE POLARSTEM EXTRACTOR BLOCK. IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED. PATIENT WAS NOT HARMED AS CONSEQUENCE TO THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268442 ↗
• MalfunctionMay 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING FIELD INSPECTION THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 AND THE POLARSTEM EXTRACTOR BLOCK WERE STRIPPED AND DID NOT ENGAGE PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793843 ↗
• InjuryMar 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR THE SURGEON USED THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 WITH THE EXTRACTION BLOCK TO IMPLANT A STEM. UPON MALLETING UPWARDS THE TIP OF THE EXTRACTOR BROKE OFF. SURGEON DECIDED TO LEAVE THE STEM IN PLACE. INSTRUMENTS INSIDE THE PATIENT. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553372 ↗
• InjuryFeb 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THESE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 WERE FOUND DEFECTIVE. ONE WAS FOUND TO BE BENT AND A THREAD CAME OFF FROM THE OTHER ONE . IT WAS REPORTED THAT THE FAILURES OCCURRED DURING USE AND A CHANGE IN SURGICAL TECHNIQUE WAS NECESSARY IN ORDER TO COMPLETE THE PROCEDURE. SECTION WAS USED TO RETRIEVE METAL SHAVINGS. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347078 ↗
• InjuryFeb 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THESE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 WERE FOUND DEFECTIVE. ONE WAS FOUND TO BE BENT ((B)(6)) AND A THREAD CAME OFF FROM THE OTHER ONE ((B)(6)). IT WAS REPORTED THAT THE FAILURES OCCURRED DURING USE AND A CHANGE IN SURGICAL TECHNIQUE WAS NECESSARY IN ORDER TO COMPLETE THE PROCEDURE. SECTION WAS USED TO RETRIEVE METAL SHAVINGS. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347069 ↗
• MalfunctionJan 19, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT SALES REP WAS SETTING UP FOR A CASE TOMORROW AND NOTICED THE INSTRUMENT WAS CROSS THREADED. IT IS UNCLEAR HOW OR WHEN THIS HAPPENED BUT IT NEEDS TO BE REPLACED. S+N BACKUP DEVICE WAS AVAILABLE. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED. DURING INVESTIGATION, IT WAS ALSO NOTICED THAT THE DEVICE SHOWS SIGNS OF CORROSION IN THE LASER MARKINGS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194639 ↗