PINNACLE ALTRX 1221-32-256Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295016212), received between Jul 21, 2017 and Dec 14, 2022 — classified as 9 injuries.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT IS TO CAPTURE THE REVISION REPORTED IN (B)(4) AND THE SUBSEQUENT ADDITIONAL INFORMATION RECEIVED (ADDED AS SOURCE DATA): REVISION DUE TO PATIENT DISLOCATING. DOI: ON (B)(6) 2022. DOR: ON (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 15978996 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON TUESDAY, (B)(6), AT (B)(6) HOSPITAL, DR. (B)(6) REVISED THE LEFT HIP OF A PATIENT WHO HAD A LEFT PRIMARY HIP ARTHROPLASTY IMPLANTED BY DR. (B)(6) AT (B)(6) HOSPITAL IN 2016. PATIENT PRESENTED IN DR. (B)(6) CLINIC WITH LEFT ANTERIOR THIGH PAIN. DR. (B)(6) ELECTED TO REMOVE THE SZ 5 TRILOCK BPS THAT WAS IN THE PATIENT TO TREAT FOR THE PAIN. DR. (B)(6) REMOVED THE 32 +9 BIOLOX DELTA FEMORAL HEAD WITH A TAMP. DR. (B)(6) THEN BEGAN REMOVING THE STEM USING A COMBINATION OF RIGID AND FLEXIBLE OSTEOTOMES AS WELL AS THE DEPUY SCREW IN FEMORAL STEM INSERTER AND ASSOCIATED SLAP HAMMER. WHILE TRYING TO REMOVE THE WELL FIXED FEMORAL STEM DR.(B)(6) FRACTURED THE PROXIMAL FEMUR. AS A RESULT, DR.(B)(6) CHOSE TO TREAT THE PATIENT WITH A COMPETITOR'S REVISION STEM. DR. (B)(6) REMOVED THE PRIMARY LINER AND REPLACE IT WITH A SZ 56X 36 +4 10 DEG ALTRX LINER TO HELP IMPROVE BIOMECHANICS. THERE WAS NO INDICATION BY ANYONE THAT THE PRODUCTS DID NOT PERFORM AS EXPECTED. NO INSTRUMENTATION BROKE DURING THE CASE. THERE WAS NO LOOSENING OF ANY COMPONENTS. DOI: 2016, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Pain

  MAUDE report 12474681 ↗
• InjuryOct 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED AND WAS REVISED TO A 56X40 +4/ 10 POLY LINER AND 40MM + 12 FEMORAL HEAD FOR IMPROVED STABILITY. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2015, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10643525 ↗
• InjuryMar 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS DISLOCATED ANTERIORLY, POST-OP (CORAIL PINNACLE TOTAL HIP REPLACEMENT VIA POSTERIOR APPROACH). HEAD AND LINER WERE REMOVED. THE VERSION OF THE CUP WAS ADJUSTED, MOVED INTO A DIFFERENT POSITION BUT WAS NOT REMOVED AND REPLACED. A NEW LINER AND HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9808357 ↗
• InjurySep 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION AND FRACTURE AFTER FIRST REVISION. DOI: (B)(6) 2014, DOR: (B)(6) 2014, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8957160 ↗
• InjuryApr 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8536375 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2011; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8137157 ↗
• InjuryDec 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2012; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7103886 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT REPORT STATED THAT PATIENT REPORTED SYMPTOMS OF EXTREME PAIN AND AMBULATION DIFFICULTIES. PATIENT HAS AN ALLERGY TO NICKEL AND VANADIUM.

  Patient problems: Pain

  MAUDE report 6732383 ↗