PINNACLE ALTRX 1221-40-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295016564), received between Aug 4, 2017 and Sep 10, 2026 — classified as 72 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (36 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Instability.DOI-Unknown.DOR- (b)(6) 2026.Affected side-Left.

  Patient problems: Joint Laxity

  MAUDE report 50715946 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. PATIENT'S PRIMARY RECLAIM MONOBLOC STEM HAD ROTATED WITHIN FEMUR, SO IT WAS REPLACE BY A LONGER RECLAIM MONOBLOC STEM. PATIENT'S PRIMARY FEMORAL HEAD AND ACETABULAR LINER WERE ALSO REPLACED BY DUAL MOBILITY COMPONENTS TO FURTHER STABILIZE THE PATIENT'S HIP. TWO WEEKS PRIOR TO THIS SURGERY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO CONVERT FAILED (CUT OUT) TROCHANTERIC NAIL TO A TOTAL HIP USING DEPUY SYNTHES COMPONENTS. THE TROCHANTERIC NAIL HAD BEEN USED A FEW WEEKS PRIOR TO REPAIR A TROCHANTERIC FEMORAL FRACTURE THE PATIENT HAD SUSTAINED. ALL THREE SURGICAL PROCEDURES WERE PERFORMED BY THE DOCTOR AT THE HOSPITAL. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24225162 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23620100 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS I/D HEAD / LINER EXCHANGE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23348097 ↗
• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE PINNACLE CUP, HEAD AND LINER WERE REVISED FOR OSTEOLYSIS AND POLYWEAR. THE LINER ALSO SHOWED MINOR YELLOWING.

  Patient problems: Osteolysis

  MAUDE report 22668515 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 2 REVISION DUE TO INFECTION. THERE WAS NO ISSUE WITH PRODUCTS AND NO TIME WASTED DUE TO PRODUCTS. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22123407 ↗
• InjuryMay 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REVISION OF HEAD, LINER, AND STEM WAS DONE FOR STABILITY ISSUES (RELATED TO POLYETHYLENE WEAR). NEEDED TO CHANGE THE STEM VERSION TO MAKE PATIENT MORE STABLE AND TO STOP IMPINGEMENT. IT WAS MENTIONED THAT THE CUP COULD HAVE BEEN MALPOSITIONED. PROCEDURE WAS NOT EXTENDED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21962448 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE SURGEON PERFORMED HEAD/LINER EXCHANGE DUE TO INFECTION DURING HIP I&D. THERE WAS NO SURGICAL DELAY IN PROCEDURE OR COMPLAINTS. IMPLANTS ARE UNAVAILABLE FOR RETURN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21902823 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND HEAD WAS BEING REPLACED FOR INSTABILITY PURPOSES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20148237 ↗
• InjuryJul 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HIS HIP WHEN STANDING FROM A DEEP-SEATED POSITION. THE EVENT DID NOT HAPPEN DURING A SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19816959 ↗
• MalfunctionJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED ANTERIOR AND POSTERIOR. SURGEON EXCHANGED THE LINER AND HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19700121 ↗
• InjuryFeb 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WITH PARKINSON¿S LOST BALANCE IN SHOWER RESULTING IN A FALL AND HIP DISLOCATION AND LOOSENING HIP PROSTHETIC. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18686606 ↗
• InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS SEND IN THE ER AT A LOCAL HOSPITAL WITH A DISLOCATED RIGHT HIP. A ORTHOPEDIC SURGEON ADMITTED THE PATIENT AND TOOK THE PATIENT TO SURGERY TO RELOCATE. THE HEAD WOULD NOT STAY IN THE CUP. THE SURGEON CONSULTED WITH THE PRIMARY SURGEON. THE PATIENT WAS TRANSPORTED FROM ONE HOSPITAL TO ANOTHER PER PRIVILEGES. A HEAD AND LINER EXCHANGE WAS PERFORMED AND DUAL MOBILITY WAS RE-IMPLANTED. THERE WAS NO INSTRUMENT BROKEN OR LOST. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18185137 ↗
• InjuryAug 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN REPLACED THE LINER THE EDGE OF THE LINER WAS CAVED IN. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17556547 ↗
• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PRIMARY HIP WAS DONE ON (B)(6) 2009. METAL LINER / HEAD WERE REVISED ON (B)(6) 2020; REASON UNKNOWN. THE STEM/ SHELL /SCREW+ REVISION LINER + HEAD WERE REMOVED ON 6-28-23 FOR INFECTION. THERE WAS OSTEOLYSIS AND A POLY WEAR REPORTED. DOI: (B)(6) 2009; (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17318343 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17172111 ↗
• InjuryMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16902358 ↗
• InjuryMay 2, 2023Noise, Audible; Noise, Audible

  (B)(6) 2021: PATIENT HAS A CONSULT REGARDING HIS RIGHT HIP WITH PERSISTENT SWELLING THAT HAS OCCURRED NEARLY A YEAR AFTER HIS REVISION. HE HAS BEEN ASPIRATED SEVERAL TIMES WITH NO SIGNS OF INFECTION. CHROMIUM AND COBALT LEVELS ARE NORMAL. HE HAS SOME NUMBNESS AND PAIN RADIATING DOWN THE BACK OF HIS LEG. MRI SHOWS A VERY LARGE PSEUDOTUMOR AROUND THE RIGHT HIP THAT HAS RECURRED AS WELL AS POSSIBLE LOOSENING OF THE RIGHT CUP. X-RAY REVIEW SHOWS OSTEOLYSIS AROUND THE STEM PROXIMALLY ON THE MEDIAL SIDE. (B)(6) 2022: PHYSICAL THERAPY NOTE INDICATES PATIENT HAD A SECOND PSEUDOTUMOR REMOVAL FROM HIS HIP ON (B)(6) 2021. HE HAS WEAKNESS AND DIFFICULTY WALKING REQUIRING PHYSICAL THERAPY TREATMENTS. IT IS UNKNOWN IF ANY IMPLANTS WERE REVISED. (B)(6) 2022: PATIENT CANCELS PHYSICAL THERAPY VISITS DUE TO EXCESSIVE ¿POPPING SOUNDS¿ IN HIS HIP. DOI: (B)(6) 2020; DOR: UNKNOWN; RIGHT HIP SECOND COMPLAINT.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Fatigue; Hypersensitivity/Allergic reaction; Metal Related Pathology; Numbness; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16852329 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED IN ORDER TO DRAIN A SEROMA THAT FORMED IN THE ILIOPSOAS MUSCLE NEAR THE ACETABULAR SHELL. THE HEAD AND LINER WERE REMOVED TO MORE EASILY ACCESS AND DRAIN THE SEROMA. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2016. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Seroma

  MAUDE report 16673283 ↗
• InjuryMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED RIGHT TOTAL HIP. REVISED TO CONSTRAINED LINER. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16551737 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED HEAD AND LINER AND REPLACED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15886083 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT UNCOMFORTABLE WITH THE CURRENT PROSTHESES. WANTED A MATCHING PROTHESES WHICH WAS A COMPETITOR HIP. THUS, THE REASON FOR REVISION AND REMOVAL. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort

  MAUDE report 15469412 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR LEFT HIP REVISED DUE TO INSTABILITY. THE SURGEON REMOVED THE CUP, LINER, AND FEMORAL HEAD LEAVING THE FEMORAL STEM. A NEW CUP AND LINER FROM COMPETITOR WAS IMPLANTED. DOI: UNKNOWN, DOR: JUL. 29, 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15233010 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PUT ON TO EXPLANT A HIP BALL , BIPOLAR SHELL AND A PINNACLE LINER BECAUSE OF INSTABILITY, AND REPLACE WITH A NEW HIP BALL AND A CONSTRAINED LINER. DURING THE PROCEDURE THE SURGEON EXPLANTED THE HIP BALL, BIPOLAR SHELL, AND PINNACLE LINER. THE SROM STEM AND PINNACLE CUP WERE LEFT IN SITU. A NEW 36MM SROM HIP BALL AND A 36MM X 56MM CONSTRAINED LINER WAS IMPLANTED. THE SURGEON WAS SATISFIED WITH THE STABILITY THIS CONSTRUCT PROVIDED. DOI: (B)(6) 2016. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12605058 ↗
• InjuryAug 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON MONDAY, (B)(6) AT (B)(6) HOSPITAL, DR (B)(6) PERFORMED A LEFT HIP REVISION ARTHROPLASTY ON A PATIENT DUE TO STEM SUBSIDENCE AND THEN INSTABILITY OF THE HIP. PATIENT¿S PRIMARY HIP WAS PERFORMED ON (B)(6) 2020 AT (B)(6) HOSPITAL BY DR. (B)(6). PATIENT EXPERIENCED A FALL THAT REQUIRED REVISION SURGERY AT (B)(6) ON (B)(6) 2021 BY DR (B)(6) WHO ELECTED TO REMOVE THE PRIMARY STEM AND REPLACE IT WITH THE COMPETITOR¿S STEM. HE RETAINED THE PRIMARY PINNACLE SECTOR 2 SHELL BUT USED A DIFFERENT POLY (REF: (B)(4)). SINCE THE (B)(6) REVISION THE PATIENT HAS EXPERIENCE INSTABILITY AND DISLOCATIONS (DR. (B)(6) CANNOT RECALL HOW MANY DISLOCATIONS). ON MONDAY, (B)(6) AT (B)(6) DR. (B)(6) EXPOSED THE JOINT SPACE, REMOVED THE LOOSE STRYKER RMS FEMORAL HEAD AND STEM. UPON INSPECTION OF THE PINNACLE ACETABULAR SHELL SZ 56 AND THE ALTRX 56/40 +4 10 DEG LINER, DR (B)(6) ELECTED TO REMOVE THEM AS WELL IN CASE OF INFECTION. DR. (B)(6) USED THE PINNACLE LINER REMOVAL TOOL TO REMOVE THE LINER AND THEN REMOVED THE WELL GROW IN PINNACLE SHELL WITH A TRIAL LINER AND ZIMMER CUP OUT SYSTEM. DR. (B)(6) IS ELECTING TO REPLACE ALL IMPLANTS WITH A TOTAL ZIMMER CONSTRUCT. NO INSTRUMENTATION BROKE DURING SURGERY. TH

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 12377336 ↗