PINNACLE GRIPTION 1217-16-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295009344), received between Oct 9, 2019 and Dec 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH HIP PAIN AND INABILITY TO BEAR WEIGHT. XRAYS SHOWED THAT THE ACETABULAR SHELL WAS NO LONGER IN PLACE AND IS THROUGH THE MEDIAL WALL. THERE WAS NON-CEMENTED LOOSENING OF THE ACETABULAR SHELL. THE PATIENT WAS ADMITTED AND SCHEDULED FOR SURGERY TO REMOVE EXISTING COMPONENTS. NO DELAY OR HARM WAS NOTED. THE PROXIMAL FEMORAL COMPONENT TO INCLUDE THE HEAD AND DM POLY LINER WERE REMOVED. ACETABULAR COMPONENT WAS ALSO REMOVED WITH NO COMPLICATION. DUE TO LACK OF BONE STOCK, NO COMPONENTS WERE REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Inadequate Osseointegration; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 20844986 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES PROVIDE INFORMATION THAT THE PRIMARY LEFT THA INCLUDED AN ASR CUP AND HEAD, A ZTT FEMORAL SLEEVE, AND AN UNK DEPUY FEMORAL STEM. DATE OF IMPLANTATION AND PART/LOT INFORMATION WERE NOT PROVIDED. THESE PRODUCTS HAVE NOT BEEN PREVIOUSLY REPORTED. RECORDS INDICATE THE PRIMARY THA PROCEDURE OCCURRED 10 YEARS EARLIER BY A DR. (B)(6). DOR: (B)(6) 2020: PATIENT RECEIVED A COMPLETE LEFT THR TO TREAT PAIN AND DISCOMFORT SECONDARY TO ARMED AND MASSIVE ACETABULAR AND FEMORAL OSTEOLYSIS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED STAINED PERIARTICULAR SYNOVIAL TISSUE AND FLUID CONSISTENT WITH METALLOSIS AND FOREIGN BODY REACTION. THE PSEUDOCAPSULE WAS DEBRIDED. THERE WAS SOME DEFICIENCY OF THE GLUTEUS MEDIUS, WHICH WAS REPAIRED. THE ASR CUP WAS MALPOSITIONED AND HAD SIGNIFICANT ECCENTRIC WEAR WHICH PRODUCED THE METALLOSIS. UPON REMOVAL OF THE ASR CUP, THE SURGEON IDENTIFIED SIGNIFICANT RETROACETABULAR OSTEOLYSIS WHICH WAS REMOVED AND RECONSTRUCTED WITH FRESH FROZEN ALLOGRAFT. THE OSTEOLYTIC LESIONS IN THE ISCHIUM, PUBIS, AND SUPERIOR REGIONS OF THE ACETABULUM, WHICH REQUIRED THE REVISION CUP TO BE SECURED WITH SCREWS. THE ZTT FEMORAL SLEEVE WAS WELL IN

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 10079884 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECENT DEEP VEIN THROMBOSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT HIP).

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10079780 ↗
• InjuryOct 9, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF AND MEDICAL RECORDS RECEIVE. PPF ALLEGED LOOSENING OF THE CUP, DISLOCATION, AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF ACETABULAR COMPONENT, SOFT TISSUE LOSS, METALLOSIS, AND DISLOCATION. OPERATIVE NOTE REPORTED OF MASSIVE SOFT TISSUE DESTRUCTION AND BROKEN 2 SCREWS. THERE WAS NO LOT NUMBER PROVIDED FOR THE BROKEN SCREWS. DOI: (B)(6) 2012 . DOR: (B)(6) 2016 (RIGHT HIP) FOURTH REVISION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Necrosis; No Code Available; Tissue Damage

  MAUDE report 9173204 ↗