PINNACLE ALTRX 1221-28-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295015925), received between Jun 2, 2020 and Dec 22, 2025 — classified as 17 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VOLUNTARY REPORT WAS RECEIVED (MW5178947). PATIENT WAS ON A TWO STEP STOOL, REACHED DOWN TO PICK UP SOMETHING ON THE FLOOR, AND IMMEDIATELY HEARD AUDIBLE. WITH EACH STEP IT WAS NOTED THE HIP WAS MAKING NOISE, HOWEVER, THE NOISE LESSENED AFTER A WEEK AND WAS HEARD DURING SPECIFIC MOVEMENTS. PATIENT THEN EXPERIENCED JOLTS AND STATED IN RETROSPECT THE AUDIBLE SOUNDS PROBABLY STARTED 4-6 MONTHS PRIOR TO (B)(6) CLINIC APPT. PATIENT SCHEDULED AN APPOINTMENT AND X-RAY SHOWED A CATASTROPHIC FAILURE OF LEFT HIP PROSTHESIS. METALLOSIS WAS NOTED WHEN SURGERY WAS DONE IN 2024. TWO REVISION SURGERIES WERE COMPLETED: 2024: LEFT HIP REVISION SURGERY. PATIENT EXPERIENCED SIGNIFICANT LEFT HIP AND LEFT FOOT PAIN, WALKING WITH A STROLLER. HEADBALL AND LINER WAS REPLACED. SIGNIFICANT METALLOSIS NOTED. ( 2024 SECOND HIP REVISION SURGERY. ACETABULAR CUP, HEADBALL AND LINER REPLACED METALLOSIS NOTED. IT WAS BELIEVED THAT THE BACK SIDE WAS DEFECTIVE. PATIENT WAS WALKING WITH A CANE/STROLLER. ORTHOPEDIC SURGEON SENT PROSTHESIS INTO DEPUY FOR REVIEW. PATIENT HAD CHEMO AND RADIATION IN 2024. PATIENT ALSO HAD CELLULITIS DIX OF LEFT FOOT. CURRENTLY, THERE IS LEG LENGTH DISCREPANCY. WALKING LONG

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Discomfort; Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 23866289 ↗
• MalfunctionJun 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2025. SURGEON OPENED A 44 NEUTRAL LINER THAT WAS FULLY SEALED IN CELLOPHANE AND THERE WAS A 64 +4 LINER INSIDE. ITEM GOT OPENED TO THE FIELD BEFORE IT WAS CAUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331338 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT DISLOCATED MULTIPLE TIMES. SURGEON WANTED TO GO TO DUAL MOBILITY. HAD TO REMOVE CUP TO GET TO A 48. NOTHING WRONG WITH PRODUCTS. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21878142 ↗
• InjuryMar 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2015. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21733371 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE HIP LINER DAMAGED AFTER CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 20409669 ↗
• MalfunctionApr 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LOCKING TAB DIDN¿T SEAT IN SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050642 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL HIP WITH A LINER DISASSOCIATION. THE ORIGINAL HIP WAS DONE BY SURGEON THE LINER DISASSOCIATED AND THE CURRENT SURGEON REVISED IT. THE LINER HAS DISASSOCIATED AGAIN, SO THE SURGEON REVISED THE ACETABULUM. THE VERSION ON THE CUP MAY HAVE CONTRIBUTED TO THE LINER DISASSOCIATING, ALONG WITH THE LOCKING MECHANISM OF THE SHELL BEING COMPROMISED DUE TO MULTIPLE DISLOCATIONS AND THE FEMORAL HEAD RUBBING ON THE SHELL. A NEW CUP WAS IMPLANTED. THE FEMORAL STEM WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18717590 ↗
• MalfunctionDec 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT LINER TAB DIDN¿T SEAT IN THE SCALLOP FLUSH AND DISENGAGED. DOE: (B)(3) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381314 ↗
• InjurySep 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED LINER DISSOCIATION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17826928 ↗
• InjuryApr 11, 2023Naturally Worn; Naturally Worn

  THE PATIENT PRESENTED WITH A HIP THAT WAS MAKING A GRINDING NOISE THAT HAD BEEN ONGOING FOR 3 MONTHS. HE HAD A PREVIOUS HIP SURGERY 9 YEARS AGO. UPON X-RAY, IT WAS DETERMINED THAT THE DELTA CERAMIC SROM HEAD HAD FRACTURED INTO 3 PIECES. THE SURGEON REMOVED THE HEAD AND LINER THAT HAD WORN THROUGH BY THE TRUNION OF THE SROM STEM. HE REPLACED WITH A METAL HEAD AND NEW ALTRX LINER. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2014, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16712358 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AND SCREWS AT BONE TO IMPLANT INTERFACE. PATIENT DEVELOPED A LARGE CYST IN THEIR SUPERIOR ACETABULUM NEAR THE ILIUM. DUE TO THIS, THE CUP AND SCREWS SHIFTED CAUSING PAIN TO THE PATIENT. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Cyst(s); Pain

  MAUDE report 16663147 ↗
• InjuryDec 19, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A PATIENT WITH AN SROM/PINNACLE BANTAM CONSTRUCT RETURNED FOR A REVISION HIP PROCEDURE AS A RESULT OF A DISASSOCIATED ALTRX LINER. THE CERAMIC FEMORAL HEAD IMPLANT WAS RUBBING AGAINST THE INSIDE OF THE PINNACLE SHELL.

  Patient problems: Insufficient Information

  MAUDE report 16003687 ↗
• InjuryOct 19, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS SUSPECTED THAT THE LINER BROKE BUT ONCE SURGEON WAS INTO THE PATIENTS HIP IT APPEARED THE LINER HAD DISASSOCIATED FROM THE CUP AND POSSIBLY SPUN AS ALL OF THE TABS ON THE LINER WERE SHEARED OFF. WAS DETERMINED THE LOCKING MECHANISM WAS STILL FUNCTIONING PROPERLY. THE SURGEON WANTED THICKER POLY, SURGEON DECIDED TO USE 22.225 ID VS 28 ID POLY. POLY WAS PLACED AND SEATED IN PLACE AND HEAD WAS PLACED AND HIP REDUCED. HIP WAS STABLE THROUGH FULL ROM. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15631705 ↗
• InjurySep 14, 2022Fracture; Fracture

  PATIENT HAD A FALL AND DAMAGED POLY INSERT. INSERT AND HEAD WERE EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Fall

  MAUDE report 15417934 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT COULD FEEL A SLIGHT ANTERIOR SUBLUXATION WHEN STANDING AND WANTED TO STABILIZE THE JOINT A LITTLE MORE. HE CHANGE THE LINER TO AN 10 DEGREE LINER AND A R THE LIP ANTERIOR LATERALLY AND THEN WENT UP TO A 28+5 BALL. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15217132 ↗
• InjuryAug 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR FAILED POLY LINER DISSOCIATION TO A NEW LINER AND REVISION HEAD. THERE WAS ALSO LOOSENING REPORTED. THERE WAS A SURGICAL DELAY OF 1 HOUR. DOI: (B)(6) 2011. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15191063 ↗
• InjuryAug 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15162925 ↗
• InjuryMar 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE AT (B)(6) ON (B)(6) 2022. SOMETIME BETWEEN THEN AND (B)(6) THE LINER DISASSOCIATED FROM THE CUP. THE SURGEON NOTICED IT ON X-RAY WHEN SHE WAS IN FOR HER 2 WEEKS FOLLOW UP AND SHE WAS IMMEDIATELY BOOKED FOR REVISION SURGERY ON (B)(6) 2022 THE SURGEON WOULD LIKE THE LINER ANALYSED AND THE MECHANISM OVER FAILURE LOOKED INTO. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP AFFECTED.

  Patient problems: Insufficient Information

  MAUDE report 13800691 ↗
• MalfunctionMar 8, 2022Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  SURGEON ATTEMPTED TO IMPACT LINER BUT IT WOULD NOT SEAT PROPERLY. LINER BECAME DISASSOCIATED AND THE DECISION WAS MADE TO NOT IMPLANT. NO SURGICAL DELAY. DOE: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 13695293 ↗
• MalfunctionNov 15, 2021Difficult to Insert; Difficult to Insert

  SURGEON COULD NOT GET POLY TO SEAT. CLAIMED SOMETHING WAS WRONG WITH LOCKING MECHANISM. THERE WAS A SURGICAL DELAY OF 5 MINUTES. DOI: UNKNOWN; DOR: (B)(6) 2021; UNKNOWN SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811250 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENTS HIP DISLOCATED POST OP, NEXT DAY CUP WAS REMOVED AND VERSION WAS CHANGED NEW SCREWS NEW LINER WERE IMPLANTED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12120799 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SHOWED UP IN ER AT AN OUTSIDE FACILITY AFTER DISLOCATING HER HIP. PATIENT WAS TRANSFERRED TO OPERATING SURGEON AS ON CALL SURGEON WAS UNABLE TO RELOCATE. COMPONENTS WELL FIXED AND WELL POSITIONED. HEAD AND LINER EXCHANGE PERFORMED WITH A 10 DEGREE LINER SHOWING EXCELLENT STABILITY. NO WEAR WAS NOR IMPINGEMENT WAS NOTED ON LINER. DOI: (B)(6) 2016 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11891691 ↗
• MalfunctionJun 9, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT REPLACED POLY LINER DUE TO WEAR. COULD NOT SEE ANY NUMBERS ON LINER. ONLY LOT NUMBER ON HEAD. NO OTHER INFO AVAILABLE. DOI: 2008, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10134899 ↗
• InjuryJun 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD ANTERIOR HIP LAST FALL AND HAD DONE WELL UNTIL ABOUT A MONTH AGO, BUT HAD DISLOCATED 2 TIMES. THE PATIENT BROUGHT TO OR FOR CUP REVISION AS IT APPEARED VIA SERIAL RADIOGRAPH THAT THE CUP HAD MOVED AT SOME POINT AND HAD INCREASED ANTEVERSION ALLOWING ANTERIOR DISLOCATION. CUP APPEARED TO HAVE APPROXIMATELY 30 DEGREES OF ANTEVERSION. SURGEON REMOVED CUP AND REPLACED WITH A DUAL MOBILITY SHELL. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10112216 ↗