NA 1521-90-059Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295276647), received between Dec 15, 2017 and Dec 3, 2025 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA ON HIP JOINT WITH THE IMPLANT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, DISLOCATION WAS CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO REPLACE THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23707739 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2012, THE PATIENT UNDERWENT A THA SURGERY WITH THE IMPLANT IN QUESTION. AFTER THE SURGERY ON AN UNKNOWN DATE, THE PATIENT WAS IN PAIN AND HAS HAD CLEANING DONE AT HOSPITAL, DUE TO THE INFECTION. HOWEVER, THE INFECTION HAS NOT SUBSIDED, SO ON (B)(6) 2025, ALL IMPLANTS IN THE PATIENT'S BODY WERE REMOVED. REOPERATION IS SCHEDULED FOR ABOUT 6-8 WEEKS LATER, WHEN THE CRP LEVEL RETURNS TO NORMAL. THE SURGEON COMMENTED THAT THE CONDITION OF THE PATIENT'S SKIN WAS NOT GOOD TO BEGIN WITH, AND THAT THE PROBLEM WAS NOT WITH THE IMPLANTS THEMSELVES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22613697 ↗
• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE CUP IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD FREQUENT DISLOCATIONS. ON (B)(6) 2023, THE REVISION SURGERY WAS DONE. DELTA 28MM+3 WAS USED NEWLY, AND THE CUP SIDE IMPLANT REPLACED TO ZB DUAL MOBILITY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPORTED THAT LINER WEAR AND NECK TRUNNIONO-SIS WERE CONFIRMED, COMMENTING THAT IT MAY BE THE EFFECT OF ¿COCR¿ AND ¿9/10¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 16530772 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2004, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR RIGHT OA WITH THE AML-PLUS AND DURALOC IMPLANTS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS DOING WELL FOR SOME TIME. THEN, THE PATIENT COMPLAINED OF DISCOMFORT, AND BECAUSE OF EXAMINATION, INFECTION WAS FOUND ON (B)(6) 2022. A REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2004, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 15734071 ↗
• InjuryJul 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THE DISLOCATION IN 2016 AND (B)(4) WHICH REPORTS REGARDING CHRONIC EXPANDING HEMATOMA AROUND THE HIP JOINT WAS DEVELOPED AFTER CONTINUED WEARING OF THE ORTHOTIC DEVICE WITHOUT REMOVING THE IMPLANTS. THIS (B)(4) WAS CREATED TO CAPTURE THE DISLOCATION IN (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 14914316 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THA IN 1991 WITH STRYKER IMPLANTS. REVISION WAS COMPLETED USING DEPUY PRODUCTS IN 2010. AFTER THE REVISION SURGERY, DISLOCATION HAD OCCURRED IN 2016 AND JUNE 2021. A SECOND REVISION WAS COMPLETED DUE TO CHRONIC EXPANDING HEMATOMA AROUND THE HIP JOINT. SINCE TRUNNIONOSIS WAS SUSPECTED, THE SURGEON DECIDED NOT TO REMOVE THE STEM AND CUT THE FEMUR DISTAL TO THE STEM. NEXT, THE SURGEON INSERTED IMPLANTS FOR TUMOR.

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14851049 ↗
• MalfunctionJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS REGARDING CHRONIC EXPANDING HEMATOMA AROUND THE HIP JOINT WAS DEVELOPED AFTER CONTINUED WEARING OF THE ORTHOTIC DEVICE WITHOUT REMOVING THE IMPLANTS. THIS PC REPORTS THAT THE DISLOCATION OCCURRED AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON UNKNOWN DATE IN 1991, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH STRYKER IMPLANTS. AFTER THE INITIAL SURGERY, A REVISION SURGERY WAS PERFORMED WITH THE HEAD AND THE STEM IN QUESTION AT MATSUDA HOSPITAL IN 2010. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE REVISION SURGERY, DISLOCATION HAD OCCURRED IN 2016 AND JUNE 2021. THEREFORE, THE PATIENT WORE THE ORTHOTIC DEVICE. THE IMPLANTS WERE NOT REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14845090 ↗
• InjuryJun 16, 2022Corroded; Corroded

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022. THE REVISION SURGERY WITH THE TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022. DURING THE REVISION SURGERY, WHEN THE SURGEON REMOVED THE INNER HEAD, BLACK RING WAS FOUND ON BOTH MATING PARTS OF THE STEM AND THE HEAD. UNEVEN WEAR AND OXIDATION DISCOLORATION WAS FOUND ON THE LINER SLIDING SURFACES. AFTER REMOVAL OF THE CUP, THE ZB¿S ADVANTAGE WAS USED FOR THE ACETABULUM SIDE. ALTHOUGH THE SALES REP EXPLAINED REGARDING THE RISKS OF USING DELTA CERAMIC HEAD, THE SURGEON FIRMLY REQUESTED TO USE THE DELTA CERAMIC HEAD. THEREFORE, THE DELTA CERAMIC HEAD WAS USED AS INNER HEAD UNDER THE SURGEON¿S RESPONSIBILITY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 14712737 ↗
• InjuryJun 15, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT IN 2005, THE PATIENT UNDERWENT THE THA SURGERY AT ANOTHER HOSPITAL. AFTER SURGERY, WHEN THE PATIENT VISITED (B)(6) HOSPITAL BECAUSE OF HIP PAIN SINCE THIS YEAR, THE PATIENT WAS FOUND TO BE INFECTED AROUND THE HIP JOINT. ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION SURGERY. IN THE REVISION SURGERY, A ZIMMER BIOMET¿S CUP WAS EXTRACTED, ZIMMER BIOMET¿S G7 AND DUAL MOBILITY WERE USED, A S-ROM STEM IMPLANTED AT THE INITIAL SURGERY WAS KEPT USING AS IT WAS, AND THE HEAD IN QUESTION WAS REPLACED WITH A NEW ONE. THE SURGEON COMMENTED THAT THE ACETABULAR SIDE SEEMED TO BE STRONGLY INFECTED. THE PATIENT HISTORY/TREATMENT HISTORY/OTHER DISEASES CURRENTLY BEING TREATED, ETC.: HYPERGLYCEMIA. THE PATIENT ALSO HAS AN ISODINE ALLERGY. NO FURTHER INFORMATION IS AVAILABLE. DOI: 2005; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14696736 ↗
• InjuryAug 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2002, THE PATIENT UNDERWENT THA. AFTER THE SURGERY, AT THE REGULAR MEDICAL EXAMINATION THIS YEAR (THE DATE IS UNKNOWN), PARTIAL WEAR OF LINER WAS CONFIRMED BY X-RAY. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY. IN THE REVISION SURGERY, LOOSENING AT THE NECK AND HEAD OF THE STEM WAS CONFIRMED. BEFORE THE REVISION SURGERY, THE REPLACEMENT OF THE STEM WAS NOT PLANNED, SO ONLY THE HEAD, LINER, AND LOCKING RING WERE REPLACED AS SCHEDULED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. WHEN THE NECK OF THE STEM WAS OBSERVED, THERE WAS A SLIGHT SCRATCH AND A SMALL AMOUNT OF BLACK POWDER ON THE NECK TAPER OF THE STEM. IT WAS CONFIRMED BY X-RAYS TAKEN AFTER THE REVISION SURGERY THAT THERE WAS NO PROBLEM. THE SURGEON IS FOLLOWING UP THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 12310394 ↗
• InjuryAug 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE THA FOR LEFT HIP WITH THE STEM, SLEEVE, LINER AND HEAD IN QUESTION. A CUP AND 4 SCREWS WERE USED BUT THEY WERE MANUFACTURED BY OTHER COMPANY. ON (B)(6) 2021, THE REVISION SURGERY WILL BE PERFORMED BECAUSE THE STEM WAS VARUS AND LOOSENED OBVIOUSLY AND THE SLEEVE WAS LOOSENED, TOO. IN THE REVISION, THE IBG (IMPACTION BONE GRAFTING) WILL BE PERFORMED, AND THE STEM WILL BE REPLACED. THE SURGEON WANTS THE CUP TO BE LEFT. THE PRESENCE OR ABSENCE OF PAIN IN THE PATIENT AND THE MECHANISM OF ONSET ARE UNKNOWN. THE DETAILS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE SURGEON COMMENTED THAT AT THE TIME OF FIRST SURGERY 10 YEARS AGO, THE STEM MIGHT HAVE BEEN INSERTED SLIGHTLY VARUS, AND THE ALIGNMENT OF THE CUP WOULD NOT BE SUCH A PROBLEM. SINCE THERE WAS NO LOOSENING IN THE CUP, IT WAS LEFT AS IT WAS, AND THE LINER WAS CHANGED FROM 28 MM TO 32 MM IN CONSIDERATION OF WEAR AND DISLOCATION RESISTANCE.

  Patient problems: Pain

  MAUDE report 12293618 ↗
• MalfunctionJul 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS RELATED TO (B)(4).THIS PC REPORTS ABOUT THE SECOND DISLOCATION AND OSTEOLYSIS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, 1991, THE PATIENT UNDERWENT THE THA SURGERY WITH UNKNOWN CUP AND STEM. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE LOOSENING OF THE CUP AND STEM OCCURRED, AND THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. AFTER THE SURGERY, THE PATIENT DISLOCATED ON AN UNKNOWN DATE, 2016. THE SURGEON COMMENTED THAT CT CAN SHOW WIDESPREAD TUMOROUS APPEARANCE AROUND THE HIP. OSTEOLYSIS CAN ALSO BE CONFIRMED. IT MAY BE A PSEUDOTUMOR SYMPTOM DUE TO COBALT CHROMIUM. CURRENTLY, REOPERATION IS POSTPONED DUE TO DECREASED RENAL FUNCTION. ON AN UNKNOWN DATE 2021, THE PATIENT DISLOCATED AGAIN AND X-RAY SHOWED OSTEOLYSIS OF THE PELVIS AND FEMUR. THE SECOND REVISION SURGERY WILL BE PERFORMED IF NECESSARY AND THE LINER AND CUP WILL BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Joint Dislocation; Osteolysis; Renal Failure

  MAUDE report 12159923 ↗
• InjuryJul 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC REPORTS ABOUT THE DISLOCATION IN 2016 AND IS RELATED TO (B)(4). IT WAS REPORTED THAT ON AN UNKNOWN DATE, 1991, THE PATIENT UNDERWENT THE THA SURGERY WITH UNKNOWN CUP AND STEM. AFTER THE SURGERY. ON AN UNKNOWN DATE, THE LOOSENING OF THE CUP AND STEM OCCURRED, AND THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. AFTER THE SURGERY, THE PATIENT DISLOCATED ON AN UNKNOWN DATE, 2016. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 12137397 ↗
• InjuryJul 1, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED IN 2010 VIA THA FOR THE PATIENT'S LEFT HIP. AFTER THE SURGERY, THE PATIENT HAD FREQUENT DISLOCATIONS, SO REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE LINER AND HEAD. WHEN THE SURGEON DEPLOYED, THE JOINT AND SOFT TISSUE WERE SCARRED. THE SURGEON REPLACED LINER AND HEAD AND MAKE SURE NOT TO DISLOCATE AND CLOSE THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE REVISION SURGERY, THE SURGEON CHECKED THE IMPLANT AND FOUND THAT THE INSIDE OF THE HEAD HAD TURNED BLACK. THE SURGEON COMMENTED THAT IT WOULD BE SOFT TISSUE NECROSIS DUE TO CO-CR WEAR POWDER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Joint Dislocation; Necrosis

  MAUDE report 12102021 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PRIMARY SURGERY WAS PERFORMED WITH THE STEM. ON (B)(6) 2017, THE FIRST REVISION SURGERY WAS PERFORMED DUE TO THE SUSPICION OF ARMD REPLACING CUP (STRYKER¿S PRODUCT) AND HEAD (UNK) WITH NEW CUP (OTHER COMPANY¿S PRODUCT) AND HEAD (152190059/D15080899). THE SECOND REVISION SURGERY WILL BE PERFORMED DUE TO INFECTION ON (B)(6) 2021 REPLACING THE STEM, HEAD AND CUP (OTHER COMPANY¿S PRODUCT). WE CREATE ONLY THIS PC BECAUSE IT IS UNKNOWN WHAT IMPLANTS HAD BEEN USED IN THE PRIMARY SURGERY AND WHAT COMPANY MANUFACTURED THE IMPLANTS. THE STEM (134522000/B4TAA1000) IMPLANTED IN THE PRIMARY SURGERY AND THE HEAD (152190059/D15080899) IMPLANTED IN THE FIRST REVISION ARE THE J&J PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. ON (B)(6), THE SECONDARY REVISION SURGERY WAS PERFORMED. IN THE REVISION, THE CUP (STRYKER'S PRODUCT) AND STEM WAS REMOVED, AND THE CEMENT AND CEMENT MOLD WERE USED AND THE REVISION SURGERY WAS COMPLETED.

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

  MAUDE report 11737140 ↗
• InjuryApr 22, 2021Degraded; Degraded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ABOUT 10 YEARS BEFORE NOW, THE PRIMARY SURGERY WAS PERFORMED WITH THE HEAD AND CUP IN QUESTION. ON AN UNKNOWN DATE, THE REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASON. IN THE REVISION, ONLY THE HEAD AND CUP WERE REMOVED, AND STEM WAS LEFT IN THE PATIENT BECAUSE THE STEM WAS NOT LOOSE. THE HEAD WAS REMOVED EASILY. THE SURROUNDING TISSUE WAS NOT DISCOLORED. THE HEAD NECK JUNCTION PART WAS SLIGHTLY DISCOLORED TO BLACK AT THE DISTAL TAPER PART. THE BLACK MATERIAL ADHERED TO THE REMOVED HEAD. THE SURGEON SUSPECTED THE ARMD AND REQUESTED THE INVESTIGATION OF THE COMPONENT ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 11706012 ↗
• MalfunctionApr 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2006, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR RIGHT HIP WITH THE IMPLANTS. ON AN UNKNOWN DATE, THE PATIENT VISITED THE HOSPITAL AND FELT STRANGE ON HER HIP, AND IT WAS CONFIRMED THAT THE DISLOCATION OCCURRED. THE REVISION SURGERY IS CONSIDERING, BUT THE EXACT DATE IS NOT SCHEDULED. IN THE REVISION, THE CUP WILL BE REMOVED, BUT THE STEM WILL NOT BE REMOVED BECAUSE IT WAS NOT LOOSENED.

  Patient problems: Joint Dislocation

  MAUDE report 11656962 ↗
• InjurySep 16, 2020Degraded; Degraded

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO ARMD. THE ARMD WAS CAUSED BY TRUNNIONOSIS AT THE POINT OF HEAD NECK JUNCTION. THE SURGEON PLANNED TO REMOVE ALL IMPLANTS AND TO REPLACE THEM AS PREOPERATIVE PLANNING, HOWEVER, DURING THE SURGERY, THE SURGEON COULD NOT REMOVE THE STEM. THE STEM WAS PULLED ABOUT 8MM BUT WAS NOT PULLED ANY MORE. THE SURGEON TRIED TO REMOVE THE STEM ABOUT 1 HOUR, AND HE ABANDONED TO REMOVE THE STEM. THE STEM WAS REMAINED IN THE BODY. IT WAS INFERRED THAT THE DIFFICULTY IN REMOVING THE STEM WAS CAUSED BY BONE¿S PENETRATION INTO THE SLOT OF DISTAL STEM. THE SURGEON REPLACED THE LINER, THE HEAD AND THE HOLE-ELIMINATOR. THE INSIDE OF EXPLANTED HEAD WAS BLACKENING. THE BLACK RING WAS SEEMED AT THE NECK. THE SURGEON REPLACED THE HEAD WITH A DELTA HEAD. THE PSEUDOTUMOR WAS OCCURRED DUE TO ARMD. THE DIFFICULTY REMOVING THE STEM CAUSED EXTENSION OF SURGICAL DURATION AND INCREASE OF BLEEDING. THE SURGERY WAS COMPLETED WITH OVER 30 MINUTES DELAY. THERE WAS SUSPICION OF INFECTION, THE SURGEON MIGHT PERFORM ANOTHER SURGERY AGAIN DEPENDING ON PATHOLOGY EXAM OF TISSUE INSIDE THE

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 10541080 ↗
• InjuryJun 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA THA AT ANOTHER HOSPITAL ((B)(6)). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD (P/N: 152190059), THE LINER (P/N: 124150000), THE CUP (P/N: 124650000) DUE TO HABITUAL DISLOCATION. THE STEM (P/N: UNKNOWN) WAS REMAINED. THE REVISION SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10133914 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 VIA THA. IT WAS CONFIRMED THAT THERE WAS LIKE TUMOR ON THE LATERAL SIDE OF FEMUR RECENTLY, AND ALTHOUGH THE PATIENT WAS UNDER OBSERVATION, THE PATIENT HAD STARTED TO COMPLAIN OF PAIN. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM (P/N: UNKNOWN), THE HEAD (P/N: UNKNOWN), THE LINER (P/N: UNKNOWN), THE HOLE ELIMINATOR (P/N: UNKNOWN). IT WAS JUDGED THAT IT WAS ARMD BECAUSE THE STEM-NECK JUNCTION HAD BEEN DISCOLORED TO BLACK. THE HIP JOINT WAS FILLED WITH PSEUDOTUMOR AND IT WAS SCRAPED AS MUCH AS POSSIBLE. THE TUMOR ON THE LATERAL SIDE OF FEMUR WAS DISAPPEARED BY SCRAPING THE PSEUDOTUMOR. THERE WAS A POSSIBILITY OF THE PSEUDOTUMOR HAD BEEN PUSHED FROM INSIDE OF THE JOINT TO THE LATERAL PART OF THE FEMUR. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Not Applicable; Pain

  MAUDE report 9711972 ↗
• InjuryDec 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019 BY EXPLANTING THE STEM (P/N: 900557210) DUE TO DISLOCATION. IT WAS CONFIRMED THAT THERE WAS CLOUDY SYNOVIAL FLUID FROM THE WOUND, SO THERE WAS A SUSPICION OF TRUNNIONOSIS, AND THE SURGERY WAS PERFORMED BY EXPLANTING ONLY THE STEM AND WASHING OUT THE WOUND PART. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Joint Dislocation; No Code Available

  MAUDE report 9424517 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONCE THE 1ST REVISION SURGERY WAS COMPLETED (IT¿S REPORTED AS (B)(4)) AND THE 2ND REVISION SURGERY WAS COMPLETED (IT¿S REPORTED AS (B)(4)). IT WAS REPORTED THAT THE 3RD REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (P/N: 121722054), THE CONSTRAINED LINER (MANUFACTURED BY ZIMMER), THE HEAD (P/N: 152190059) DUE TO DISLOCATION FROM THE CUP. THE SURGEON CONSIDERED THAT THE CAUSE OF DISLOCATION WAS CAUSED BY THE LOADING OF THE CONSTRAINED LINER. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8482194 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2014, PRIMARY THA SURGERY WAS PERFORMED USING THE FOLLOWING IMPLANTS. -STEM (PART#: 900530210, LOT#: 7834133). -SLEEVE (PART#: 550514, LOT#: 7807209). -HEAD (PART#: 152190059, LOT#: 3269026). -LINER (PART# & LOT#: UNKNOWN). -CUP (PART# & LOT#: UNKNOWN). IN (B)(6) 2017, PSEUDOTUMOR WAS SUSPECTED BASED ON THE MRI IMAGE AT THIS HOSPITAL. IN (B)(6) 2017, PSEUDOTUMOR WAS DENIED THROUGH THE NEEDLE BIOPSY AT ANOTHER LARGE HOSPITAL. IN (B)(6) 2017, THIS HOSPITAL CONFIRMED THROUGH MRI THAT THE PSEUDOTUMOR WAS GETTING BIGGER. ON (B)(6) 2017, REVISION SURGERY WAS PERFORMED TO REPLACE ALL THE IMPLANTS OTHER THAN THE CUP WITH NEW IMPLANTS. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. DOI: (B)(6) 2014; DOR: (B)(6) 2017; UNKNOWN AFFECTED HIP.

  Patient problems: Tissue Damage

  MAUDE report 7120992 ↗