PINNACLE GRIPTION 1217-31-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295010227), received between Jan 25, 2018 and Dec 1, 2025 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23679799 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SAFETY DATA SHEETS WERE NEEDED ON THESE THREE PRODUCTS DUE TO AN INVESTIGATION CONCERNING ALLERGIC REACTIONS. THE PATIENT IS GOING TO HAVE A SECOND SURGERY IN THE BEGINNING OF (B)(6).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21137084 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 19259289 ↗
• MalfunctionAug 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN PACKAGE WAS OPENED THERE WERE LITTLE BLACK DOTS INSIDE THE CLEAR SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597229 ↗
• MalfunctionJul 6, 2022Difficult to Insert; Difficult to Insert

  THE SURGEON REPORTED THAT THE HOLE ELIMINATOR THREADED RIGHT THROUGH THE HOLE OF THE PINNACLE CUP. HE HAD TO REMOVE THE CUP AND START AGAIN WITH A NEW CUP AND HOLE ELIMINATOR.

  Patient problems: Insufficient Information

  MAUDE report 14932793 ↗
• InjuryJun 22, 2022Use of Device Problem; Use of Device Problem

  PINNACLE FIRST IMPLANTATION (B)(6) 2022 TOO MEDIAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-(B)(6). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-(B)(6). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-(B)(6). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: Insufficient Information

  MAUDE report 14774598 ↗
• InjuryMay 25, 2022Use of Device Problem; Use of Device Problem

  MAL POSITION OF THE CORAIL PINNACLE. NO ANTEVERSION ON THE CORAIL. PINNACLE TO MUCH ANTEVERSION 50 DEGREES WITH IMPEACHMENT. DOE: (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14495299 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING REVISED TODAY FOR CHRONIC INFECTION, ALL COMPONENTS WERE REMOVED AND A PROSTALAC SPACER WAS PLACED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 12829036 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  POST THA THE PATIENT CAME BACK WITH A DISSOCIATED PINNACLE POLY LINER LEADING TO X-RAY AND WILL BE REVISED. THERE WAS NOT A DEPUY HEAD , THEY HAVE PUT IN A HYBRID VERSION WITH A STEM AND HEAD FROM Z/B. DUE TO THE METAL DEBRIS IN THE JOINT THE OR TIME WAS LONGER THAN EXPECTED. APPROXIMATELY 30-45 MINUTES TO CLEAN OUT THE METAL DEBRIS FROM THE TISSUES IN THE JOINT. THERE WAS A LOT OF METAL DEBRIS IN THE HIP JOINT WITCH WAS REMOVED AND A NEW ALTRX LINER WAS IMPLANTED. THE PINNACLE CUP-121731056 LOT NR 9660625 WAS A BIT WORN ON THE EDGE BUT MOSTLY THE DEBRIS CAME FROM THE METAL HEAD FROM Z/B THAT ALSO WAS EXCHANGED. THE HEAD AND STEM IS FROM Z/B. THE PATIENT IS A MALE AND THE AFFECTED SIDE IS RIGHT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11590686 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT 4 WEEKS POST SURGERY, THE PATIENT CAME BACK WITH HIP PROBLEMS AND NOISE FROM THE HIP. THE CAUSE WAS POLY LINER DISSOCIATION LEADING TO REVISION SURGERY AND EXCHANGE OF THE POLY LINER. THE PINNACLE CUP WAS LEFT WELL FIXED, ONLY LINER EXCHANGE WAS PERFORMED. NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11590521 ↗
• MalfunctionNov 16, 2020Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO SURGICAL DELAY, PATIENT DID NOT RELEVANT SURGERIES BEFORE. THIS WAS A PRIMARY SURGERY AND LEFT SIDE WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843460 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED INFECTION. PFS ALLEGED PAIN, REDNESS, AND DRAINAGE. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT INFECTED TOTAL HIP ARTHROPLASTY. UPON PHYSICAL EXAMINATION ON (B)(6) 2018, PATIENT HAS FEVER. PAIN, SWELLING, REDNESS, DRAINAGE, THROBBING FRONTAL HEADACHE, SQUEEZING CHEST PAIN, AND FATIGUE WERE ALLEGED. PATIENT SAID INCISION IS DRAINING YELLOW TO BROWN FLUID BUT DRAINAGE HAS NO ODOR. OPERATIVE NOTES INDICATED A COMMUNICATION WAS FOUND BETWEEN THE SUPERFICIAL SPACE AND DEEP TO THE FASCIA. THE SUPERFICIAL SPACE WAS DEBRIDED. AN EXCISIONAL DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, FAT AND THE FASCIA WERE DONE. THE SUPERFICIAL SPACE WAS THEN COPIOUSLY IRRIGATED. THERE WAS FLUID DEEP TO THE FASCIA WITH PURULENCE ABOUT 80 CC OF PURULENT FLUID. THE CAPSULE WAS DEBULKED AND SCAR TISSUE WAS REMOVED. SCAR TISSUE WAS ALSO REMOVED AROUND THE ACETABULAR COMPONENT. A THOROUGH DEBRIDEMENT OF AN INFECTED LOOKING TISSUE WAS DONE AROUND THE ACETABULUM AND FEMUR. AFTER ALL INFECTED LOOKING TISSUES WERE EXCISED THE HIP WAS IRRIGATED WITH 9 LITERS OF IRRIGATION AS WELL AS BETADINE IRRIGATION. BASED ON FLUOROSCOPY, THERE WAS NO IATROGENIC FRACTURES. LABORATORY RESULTS IN

  Patient problems: Adhesion(s); Chest Pain; Edema; Erythema; Fatigue; Fever; Headache; No Code Available; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 9836929 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. PFS HAS NO ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, UPON PHYSICAL EXAMINATION LAST (B)(6) 2018, PATIENT HAS FEVER. THROBBING FRONTAL HEADACHE, SQUEEZING CHEST PAIN, AND FATIGUE WERE ALLEGED. CT SCAN SHOWED MINIMAL FLUID TRACKING ANTERIOR TO THE RIGHT HIP REPLACEMENT. LABORATORY RESULTS INDICATED INFECTION. DOI: (B)(6) 2018 (HEAD & LINER); DOR: NONE REPORTED (RIGHT HIP). DOI: (B)(6) 2011 (CUP AND LINER).

  Patient problems: Chest Pain; Edema; Fatigue; Fever; Headache; No Code Available; Pain; Unspecified Infection

  MAUDE report 9836547 ↗
• InjuryJun 20, 2019Migration; Migration

  IT WAS REPORTED THAT THE CUP SHIFTED DUE TO A FALL. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8717558 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISASSOCIATED LINER REMOVED AND REPLACED WITH NEW 36/56 NEUTRAL LINER. CERAMIC HEAD REMOVED AND REPLACED BY DETLA TS CERAMIC 36 +5 HEAD.

  Patient problems: No Information

  MAUDE report 8515150 ↗
• InjuryFeb 4, 2019Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO DISCOMFORT AND VISIBLE BONE LOSS. UPDATE PINNACLE MOM LITIGATION RECORD: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION ALLEGES PAIN AND INJURIES WHICH INHIBITED THE PATIENT'S ABILITY TO MOVE. PATIENT ALSO SUFFERED ACETABULAR CUP DETACHMENT, DISCONNECTION, CREATION OF METALLIC DEBRIS, AND/OR LOOSENING. DOI: (B)(6) 2010, DOR: (B)(6) 2016, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

  MAUDE report 8300812 ↗
• InjuryFeb 9, 2018Malposition of Device; Malposition of Device

  DER STATED THAT PATIENT HAD HIP PAIN AND SAXONY SURGEON DIDN'T LIKE THE CUP POSITION. TOOK OUT THE CUP, LINER AND HEAD PUT IN A NEW CUP AND HEAD. IT WAS ALSO REPORTED THAT PROXIMAL PART OF THE STEM APPEARS LOOSE AT THE BONE TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN, AS THEY COULD WIGGLE IT WITH AN OSTEOTOME BETWEEN THE NECK AND THE GREATER TROCHANTER. USED OSTEOTOMES AND SLAP HAMMERS TO TRY TO EXTRACT STEM FOR AN HOUR BUT STEM TOO FIXED DISTALLY SO LEFT IN STEM AND USED HYDROSET AROUND THE STEM TO REFIXATE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 7258770 ↗
• InjuryJan 25, 2018Disassembly; Disassembly

  PATIENT HEARD A POP AFTER A FALL. PINNACLE LINER DISASSOCIATED FROM ACETABULAR CUP. THREE (3) WEEKS POST OP. PRODUCTS REMOVED WERE 36X56 NEUTRAL ALTRX LINER AND 36+1.5 BIOLOX CERAMIC HEAD LOT NUMBER IS 8651122. THERE WERE NO SURGICAL DELAYS. NO ADDITIONAL CONCERNS STATED BY SURGEON. PATIENT CONSEQUENCE DESCRIPTION:REVISION SURGERY FOR HEAD AND LINER EXCHANGE.

  Patient problems: No Code Available

  MAUDE report 7218440 ↗