SOLUTION SYSTEM 1257-60-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295019930), received between Oct 26, 2017 and May 19, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 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) IN (B)(6). DOR: (B)(6) 2020: PATIENT RECEIVED A COMPLETE LEFT THR TO TREAT PAIN AND DISCOMFORT SECONDARY TO ARMD 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

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 10072777 ↗
• InjuryMay 19, 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. EDWARDS IN LARAMIE, WYOMING. DOR: (B)(6) 2020: PATIENT RECEIVED A COMPLETE LEFT THR TO TREAT PAIN AND DISCOMFORT SECONDARY TO ARMD 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

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10072341 ↗
• InjuryJan 11, 2019Break; Loss of Osseointegration; Break; Loss of Osseointegration

  PATIENT WAS REVISED FOR A LOOSE ACETABULAR COMPONENT. THERE WAS A BROKEN SCREW.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8241159 ↗
• InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, MUSCLE AND BONE SEPARATION AND SWELLING. UPDATE AFTER REVIEW OF THE MEDICAL RECORDS, THE REVISION SURGERY NOTES METALLOSIS, AND THE PATIENT DISLOCATED ONCE. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND LOOSENING OF CUP. DOI: (B)(6) 2007- DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8137245 ↗
• InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, MUSCLE AND BONE SEPARATION AND SWELLING. UPDATE AFTER REVIEW OF THE MEDICAL RECORDS, THE REVISION SURGERY NOTES METALLOSIS, AND THE PATIENT DISLOCATED ONCE. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND LOOSENING OF CUP. DOI: (B)(6) 2007, DOR: AUG 24, 2015, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8137216 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE THAT DEFECTIVE PRODUCT WAS THE CAUSE OF ANY PAIN OR OTHER PROBLEMS SHE MAY EXPERIENCE. DOI: (B)(6) 2007; DOR: NONE REPORTED; (RIGHT HIP). PATIENT IS RESIDES IN (B)(6). UPDATE: 10/18/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. AS THE LITIGATION HAS ALREADY BEEN REPORTED, AND THERE IS NO REPORTED SERIOUS INJURY OR MALFUNCTION (PATIENT HAS NOT BEEN REVISED), THE REPORTING REQUIREMENTS HAVE BEEN MET. EVEN THOUGH PART/LOT INFORMATION WAS PROVIDED IT IS UNCLEAR WHAT PRODUCTS ARE AT ISSUE AS THE PATIENT HAS NOT BEEN REVISED THEREFORE THE PRODUCT PAGE WILL BE LEFT AS UNKNOWN UNTIL FURTHER INFORMATION IS RECEIVED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 19 APRIL 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF, STICKER SHEETS AND MEDICAL RECORDS. THERE WERE NO NEW ALLEGATION IN PPF NOR IN THE MEDICAL RECORDS. HOWEVER, IN THE PREVIOUS PFS

  Patient problems: Pain

  MAUDE report 7788385 ↗
• InjuryAug 2, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND COMPONENT FRACTURE . DOI: (B)(6) 2008; DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 7742187 ↗
• InjuryOct 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAS OBSERVED THAT THIS IMPLANT HAS UNSCREWED FROM A PERIPHERAL SCREW HOLE ON A PINNACLE REVISION CUP.

  Patient problems: No Information

  MAUDE report 6982615 ↗