NA 1521-90-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295276579), received between May 22, 2018 and Sep 18, 2024 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL SURGERY ON (B)(6) 2001, FOR A TOTAL HIP ARTHROPLASTY (THA). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. POST-OPERATIVELY, THE PATIENT HAS RECENTLY EXPERIENCED REPEATED DISLOCATIONS. A REVISION SURGERY WILL BE SCHEDULED DUE TO THE REPEATED DISLOCATIONS. IN THE REVISION SURGERY, THE LINER AND HEAD WILL BE REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 20250592 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR OA FOR THE HIP JOINT WITH THE CUP AND STEM IN QUESTION AT THIS HOSPITAL. THE DATE IS UNKNOWN, BUT THE FEMORAL STEM IN QUESTION WAS FOUND TO HAVE SUNK, SO THE STEM IN QUESTION WILL BE REMOVED, AND REVISION SURGERY WILL BE PERFORMED. REVISION SURGERY SCHEDULED FOR (B)(6) 2024. THE SURGEON'S OPINION WAS THAT THE CAUSE OF THE STEM SINKING WAS PROBABLY A DELAYED INFECTION. THE SURGEON WANTS TO REPLACE ONLY THE LINER, WHICH MAY DETERIORATE OVER TIME, SINCE THE CUP SIDE IS IN JUST BARELY SCRAPED OFF THE INNER PLATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18358163 ↗
• InjuryMay 25, 2023Device Dislodged or Dislocated; No Apparent Adverse Event; Device Dislodged or Dislocated; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED. ON MAY 29, 2023, THE REVISION SURGERY WAS PERFORMED FROM 9:15AM. THE SURGEON REMOVED THE BIPOLAR CUP AND THE HEAD WITH BONE FRAGMENT PUNCHING MACHINE. THE LOOSENING OF THE STEM WAS NOT CONFIRMED AND IT WAS PRESERVED. THE CUP WAS REPLACED TO ZB'S G7 AND ARGUMENT IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH DUAL MOBILITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002885 ↗
• InjuryNov 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2002, THE PATIENT UNDERWENT THE SURGERY FOR OA VIA THA WITH THE DURALOCK IMPLANTS IN QUESTION AND AML-PLUS STEM. AFTER THE SURGERY, THE PATIENT HAD FREQUENT DISLOCATIONS. ON (B)(6) 2022, THE PATIENT UNDERWENT THE REVISION SURGERY, AND REPLACED THE CUP, LINER, AND HEAD. THE STEM HAS BEEN PLACED AS IS SINCE PRIMARY SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15716084 ↗
• InjuryJul 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS RELATED TO (B)(4) AND (B)(4). (B)(4) REPORTS ABOUT THE FIRST REVISION SURGERY PERFORMED AFTER THE PRIMARY SURGERY. (B)(4) REPORTS ABOUT THE DISLOCATION OCCURRED ON (B)(6) 2021, AFTER THE FIRST REVISION SURGERY. IN THIS PC, WE REPORT ABOUT THE DISLOCATION OCCURRED ON (B)(6) 2021, AFTER THE FIRST REVISION SURGERY. ON (B)(6) 2021, DISLOCATION OCCURRED AGAIN WHEN THE PATIENT DID THE SAME POSTURE AS THE DISLOCATION SHE HAD ON (B)(6) 2021. THE IMPLANTS WERE LOOSENED. THE POLYETHYLENE LINER WAS WORN OUT, AND THE PATIENT WALKING WAS ALSO UNSTABLE. IN ADDITION, THE STEM ALSO SHOWED A SLIGHT INTERNAL DEFORMITY. THEREFORE, A SECOND REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE CUP, THE HEAD, AND THE STEM WILL BE REPLACED. THE SURGEON PLANS TO LEAVE THE SLEEVE. THE STEM AND THE HEAD WILL BE DISCARDED. THE LINER AND CUP ARE COMPETITOR¿S PRODUCTS. MEDICAL/THERAPEUTIC HISTORY/OTHER DISEASES CURRENTLY TREATED, ETC: DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDAEMIA, HYPERURICAEMIA, HEPATITIS C NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15132236 ↗
• InjuryJul 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE FIRST REVISION SURGERY WAS PERFORMED AFTER THE PRIMARY SURGERY. THIS PC REPORTS THAT DISLOCATIONS HAD OCCURRED TWICE AFTER THE FIRST REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6), 2011, THE PATIENT UNDERWENT THE FIRST REVISION SURGERY WITH THE CUP (ZB¿S PRODUCT), THE HEAD, AND THE SROM STEM. THE FIRST REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, DISLOCATIONS HAD OCCURRED TWICE. ON (B)(6), 2021, DISLOCATION OCCURRED WHILE IN MID-BACK POSITION, SO THAT THE PATIENT WAS HOSPITALIZED. ON (B)(6), 2021, DISLOCATION OCCURRED AGAIN WHILE IN THE SAME POSITION. THE IMPLANTS WERE LOOSENED. THE POLYETHYLENE LINER WAS WORN OUT, AND THE PATIENT WALKING WAS ALSO UNSTABLE. IN ADDITION, THE STEM ALSO SHOWED A SLIGHT INTERNAL DEFORMITY. THEREFORE, A SECOND REVISION SURGERY WILL BE PERFORMED ON (B)(6), 2022. THE CUP, THE HEAD, AND THE STEM WILL BE REPLACED. THE SURGEON PLANS TO LEAVE THE SLEEVE. THE STEM AND THE HEAD WILL BE DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15111530 ↗
• InjuryJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE DISLOCATION OCCURRED AFTER THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE DISLOCATION OCCURRED AFTER THE 1ST REVISION SURGERY. FIRST REVISION COMPLETED TO ADDRESS DISLOCATION. SECOND REVISION COMPLETED TO ADDRESS DISLOCATION. IN THE SECOND SURGERY, THE METAL LINER, STEM, AND HEAD WERE REPLACED. DOI:(B)(6) 2009; DOR:(B)(6) 2022; DOR: (B)(6) 2022 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14563570 ↗
• MalfunctionMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 4TH DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14396123 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 7TH DISLOCATION OCCURRED. TO CHANGE THE ANTEVERSION ANGLE OF THE CUP THIS TIME, A REVISION SURGERY TO REPLACE THE CUP AND HEAD WILL BE HELD. THE STEM WILL BE REMAINED IN THE BODY AS IT IS SINCE IT HAS NO WEAR OR DETERIORATION ON ITS NECK. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357776 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 6TH DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357644 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 5TH DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357520 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 3RD DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357507 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 2ND DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357419 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REPORTED IN THIS PC IS THE SAME PATIENT REPORTED IN (B)(4). IT WAS REPORTED THAT ON UNKNOWN DATE IN 2010, THE PATIENT UNDERWENT A PRIMARY SURGERY VIA THA AT ANOTHER HOSPITAL. AFTER SURGERY, ON UNKNOWN DATE, THE 1ST DISLOCATION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14357331 ↗
• InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 2019, THE PATIENT UNDERWENT THE SURGERY WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT HAD FREQUENT DISLOCATIONS. REVISION WAS PLANNED ON AN UNKNOWN DATE TO REPLACE THE CUP AND HEAD. SIZE UP THE HEAD DIAMETER FROM 22.225 TO 28. THE NECK LENGTH ALSO INCREASES FROM + 0 TO + 3. NO FURTHER INFORMATION IS AVAILABLE. DOI: 2019; DOR: UNKNOWN; UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 13719617 ↗
• MalfunctionOct 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ABOUT 20 YEARS AGO, THE PATIENT UNDERWENT THE THA SURGERY AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN THIS YEAR, DISLOCATION OCCURRED. THE PATIENT¿S CONDITION HAD BEEN FOLLOWED UP, BUT IT WAS DECIDED TO PERFORM REVISION SURGERY ON (B)(6) 2021. THE HEAD AND A CUP WILL BE REPLACED. THE CUP IS OTHER COMPANY¿S PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 12671488 ↗
• InjuryJul 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2006, THE PATIENT UNDERWENT THE SURGERY WITH THE STEM, SLEEVE, HEAD. THE CUP IS OTHER COMPANY¿S PRODUCT. ON (B)(6) 2021, THE REVISION SURGERY WILL BE PERFORMED DUE TO DISLOCATION. THE LINER, HEAD AND STEM WILL BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. ON (B)(6) 2021, THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SLEEVE WAS LEFT. THE HEAD AND STEM WAS REPLACED WITH THE NEW HEAD AND STEM (STEM: 900573210, HEAD: 152190051). THE SURGEON ALSO TRIED TO REPLACE THE CUP SIDE, BUT DID NOT REPLACE THE CUP SIDE BECAUSE OF THE RISK OF INVASION WHEN REMOVING THE CUP. THE SURGEON COMMENTED THAT IT WOULD HAVE BEEN MORE EFFECTIVE IF THE CUP COULD HAVE BEEN REMOVED. THE SURGEON HAD DIFFICULTY IN REMOVING THE STEM BECAUSE THE STEM WAS LONG TYPE.

  Patient problems: Joint Dislocation

  MAUDE report 12153486 ↗
• InjuryJun 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED WITH MANUFACTURED BY OTHER COMPANY IMPLANTS VIA THA (DATE OF PRIMARY SURGERY WAS UNKNOWN). THE 1ST REVISION SURGERY WAS PERFORMED WITH THE SOL-P STEM (P/N: UNKNOWN), THE SOL-P HEAD (P/N: UNKNOWN) ON (B)(6) 2002. IT WAS REPORTED THAT 2ND REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2019 BY REPLACING THE HEAD (P/N: UNKNOWN) DUE TO DISLOCATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 8716137 ↗
• InjuryMay 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED IN 2003. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED (THE DATE OF REVISION WAS UNKNOWN) DUE TO DISLOCATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: 2003; DOR:UNKNOWN; UNKNOWN HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7533640 ↗