PINNACLE 2218-32-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295100706), received between Dec 12, 2017 and Apr 29, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031595 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031589 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026682 ↗
• MalfunctionApr 22, 2026Device-Device Incompatibility; Material Deformation

  MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL PIN TRL LNR NEUT 48ODX32ID (221832048) : NOT APPLICABLE, PIN TRL LNR NEUT 50ODX32ID (221832050) : NOT APPLICABLE, PIN TRL LNR NEUT 520DX36ID (221836052) : NOT APPLICABLE, PIN TRL LNR NEUT 540DX36ID (221836054) : NOT APPLICABLE, WAS THERE ANY REPORTED PATIENT OR USER HARM? NO, WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954814 ↗
• MalfunctionNov 12, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, THE STAFF NOTICED LARGE GOUGES AND DENTS TAKEN OUT OF THE PLASTIC OF THIS NEUTRAL LINER TRIAL, AND IT CAN NO LONGER BE USED TO PROPERLY TRIAL THE HIP CONSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536601 ↗
• MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ITEM WAS REPORTED MISSING BY CSSD MANAGER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816937 ↗
• MalfunctionJun 18, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED SEVERAL PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR, AS WELL AS NO LONGER THREADING PROPERLY INTO THE TRIAL SHELL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284945 ↗
• MalfunctionFeb 25, 2025Crack; Crack

  IT WAS REPORTED THAT TRIAL LINERS WERE WORN/CRACKED. SCREWS ARE WORN AND CRACKS IN THE PLASTIC. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462898 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT THE 32X40 NEUTRAL TRIAL LINER BROKE AND ARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291300 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT LINER TRIALS (48,50MM) WERE BROKEN. ATTUNE ARTICULAR SURFACE TRIALS (5,6 FB) WERE ALSO BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595642 ↗
• InjuryJan 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A DELAY OF APPROXIMATELY 1 HOUR.

  Patient problems: Insufficient Information

  MAUDE report 16246274 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615874 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CLEANING PROTOCOL RECEIVED FROM THE HOSPITAL: THE CUSTOMER STATED THAT: WHEN THE TRAYS ARRIVE IN DECONTAMINATION THEY ARE SOAKED IN THE ENZYMATIC SOLUTION FOR 5 MINUTES AND ARE THEN MANUALLY CLEANED BY AN MDRT. AFTER THAT, THEY GO INTO OUR ULTRASONICS FOR 10 MINUTES. WHEN THEY COME OUT OF THE ULTRASONIC, WE PUT THEM THROUGH OUR AUTOMATED INSTRUMENT WASHERS. ONCE THE TRAYS COME OUT OF THE WASHERS ON OUR "CLEAN" SIDE, WE DRY THE CONTENTS, CHECK THEM FOR SOIL, ASSEMBLE AS NECESSARY AND THEN THEY GO INTO OUR AUTOCLAVE ON THE STANDARD CYCLE OF 4MIN AT 270 DEGREES F. THE ENZYMATIC SOLUTION WE USE IN THE SOAK AND MANUAL CLEAN STEP IS A STERIS PRODUCT CALLED VALSURE ENZYMATIC CLEANER. WE MIX IT AT 1/2OZ VALSURE TO 1 GALLON OF WATER. THE OTHER PRODUCTS WE USE ARE AUTOMATED WASHERS. THEY ARE ALL STERIS PRODUCTS. WE USE PROLYSTICA ENZYMATIC CLEANER, PROLYSTICA NEUTRAL DETERGENT AND PROLYSTICA LUBRICANT NON-SILICONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615754 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615746 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615729 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CLEANING PROTOCOL RECEIVED FROM THE HOSPITAL: THE CUSTOMER STATED THAT: WHEN THE TRAYS ARRIVE IN DECONTAMINATION THEY ARE SOAKED IN THE ENZYMATIC SOLUTION FOR 5 MINUTES AND ARE THEN MANUALLY CLEANED BY AN MDRT. AFTER THAT, THEY GO INTO OUR ULTRASONICS FOR 10 MINUTES. WHEN THEY COME OUT OF THE ULTRASONIC, WE PUT THEM THROUGH OUR AUTOMATED INSTRUMENT WASHERS. ONCE THE TRAYS COME OUT OF THE WASHERS ON OUR "CLEAN" SIDE, WE DRY THE CONTENTS, CHECK THEM FOR SOIL, ASSEMBLE AS NECESSARY AND THEN THEY GO INTO OUR AUTOCLAVE ON THE STANDARD CYCLE OF 4MIN AT 270 DEGREES F. THE ENZYMATIC SOLUTION WE USE IN THE SOAK AND MANUAL CLEAN STEP IS A STERIS PRODUCT CALLED VALSURE ENZYMATIC CLEANER. WE MIX IT AT 1/2OZ VALSURE TO 1 GALLON OF WATER. THE OTHER PRODUCTS WE USE ARE AUTOMATED WASHERS. THEY ARE ALL STERIS PRODUCTS. WE USE PROLYSTICA ENZYMATIC CLEANER, PROLYSTICA NEUTRAL DETERGENT AND PROLYSTICA LUBRICANT NON-SILICONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615710 ↗
• MalfunctionAug 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LINER TRIAL WAS NOT THREADING INTO CUP AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192565 ↗
• MalfunctionJul 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE LINER TRIALS IN QUESTION. DURING THE SURGERY, AFTER THE LINER TRIALS WAS INSERTED, WHEN THE SURGEON REMOVED THE LINER TRIALS TO INSERT THE REAL LINER, THE LINER TRIALS HAD BEEN BROKEN. TWO PLACES ON THE EDGE OF THE LINER TRIALS WERE CRACKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221409 ↗
• MalfunctionJun 10, 2021Scratched Material; Scratched Material

  DER STATED "SCRATCHED DURING STERILIZATION". CANNOT BE REPROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975589 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED AS "BROKEN IN STERILIZATION". NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864470 ↗
• MalfunctionFeb 23, 2021Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT GRATER CASE IS BENT WHERE HANDLES FIT AND REAMER HANDLES ARE DROPPING IN AND WONT COME OUT DEPTH GAUGE IS BENT AND TIP IS UNUSABLE POLY TRIALS HAVE THE SCREWS BROKEN OFF AT THE DOME AND CAN¿T BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369005 ↗
• MalfunctionDec 8, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  METAL SHARDS HAVE BEEN FOUND WITHIN THE OUTER AND INNER SURFACES OF THIS TRIAL. INFORMATION SUPPLIED INDICATES THAT THIS WAS THE FIRST TIME USE OF THIS TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969657 ↗
• MalfunctionJul 14, 2020Crack; Crack

  RIM CRACKED DURING TRAIL REDUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272056 ↗
• InjuryMay 20, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. AFTER THE PRIMARY SURGERY, THE HOSPITAL FOUND THAT THE TRIAL LINER (P/N: 221832048) WAS LOST. THE TRIAL LINER WAS NOT FOUND EVEN THE HOSPITAL SEARCHED IT. ON END OF (B)(6) 2020, THE DISLOCATION WHICH WAS CAUSED BY CUP¿S ANTERIOR OPENING ANGLE WAS CONFIRMED. ON (B)(6) 2020, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE CUP (P/N: UNKNOWN), THE HEAD (P/N: UNKNOWN) AND THE TRIAL LINER (P/N: 221832048) DUE TO THE DISLOCATION. DURING THE SURGERY, WHEN REMOVING THE LINER, THE SURGEON FOUND THAT THE IMPLANTED LINER WAS THE TRIAL LINER. AT THE PRIMARY SURGERY, THE SURGEON HAD NOT NOTICED THAT THE IMPLANTED LINER WAS THE TRIAL LINER. THE REVISION SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10075058 ↗
• MalfunctionNov 5, 2018Break; Break

  ACETABULAR LINER TRIAL BROKE DURING SURGERY. ALL PIECES RECOVERED WITH NO DELAY OR EXTENDED SURGICAL TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039294 ↗