TRANSCEND® 26000026Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M684260000261), received between May 30, 2019 and Sep 8, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: F. OTHER LEGAL MANUFACTURER: PRODUCT ID: 6310-60-36 LONGEVITY UHMW POLYETHYLENE LINER 60MMX36MM ELEV RIM 10 DEG ZIMMER BIOMET.

  Patient problems: Unspecified Infection

  MAUDE report 22999146 ↗
• InjuryJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION/INFECTION/ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. SRNJR NUMBER: 5116346. SIDE: R. GENDER: M. NON REVISED PRODUCTS: PRODUCT ID: PPW39122 PROFEMUR® R HA COATED PROX BODY SMALL V4/ LOT. NO: 127487759/ QTY: 1. PRODUCT ID: PPW38000 PROFEMUR® 135MM STEM STRAIGHT/TAPER SIZE 10/ LOT. NO: U0266735/ QTY: 1.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 19614647 ↗
• InjuryJun 21, 2024Use of Device Problem; Use of Device Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO HEAD/SOCKET MISMATCH - SOCKET. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M. NON MPO DEVICES: 121712064 PINN SECTOR HA ACET CUP 64MM, 121936164 PINNACLE MARATHON PE LINER +4 10 DEGREE 64X36MM AND 121730500 PINNACLE 6.5 CANCELLOUS SCREW 30MM (DEPUY).

  Patient problems: Insufficient Information

  MAUDE report 19586530 ↗
• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, UNEXPLAINED PAIN. SIDE: R. REVISION NJR: (B)(6). GENDER: F, EXPLANTED: FEMORAL STEM, ACETABULAR CUP.

  Patient problems: Pain

  MAUDE report 18792158 ↗
• InjuryFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, REVISION DONE DUE TO PAINFUL HIP. THEY TOOK OUT THE STEM, NECK, HEAD AND POLY. THEY REPLACE THE POLY. PRODUCTS NO REVISE: PRODUCT: DSBFGD52 DYNASTY® BF SHELL 52MM GROUP D, LOT: 1502022, QTY: 1.

  Patient problems: Pain

  MAUDE report 18687000 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PT UNDERWENT L THR ON (B)(6) 2019. REVISED ON (B)(6) 2023 DUE TO A SUSPECTED LOW GRADE INFECTION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED TO ALLOW WASH OUT OF THE ACETABULAR SHELL AND STEM SURFACES. AUSTRALIA (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17739815 ↗
• InjuryMar 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT IN (B)(6) 2010 REPLACEMENT OF THE RIGHT HIP BY MEANS OF A METAL-METAL PROSTHESIS IMPLANTATION, HAS DEVELOPED PSEUDO-TUMOR FROM METAL-METAL COUPLING, WITH EVIDENCE OF A COBALT DOSAGE OF 7.7 MG / L (COMPARED TO REFERENCE <1.0MG / L), CAUSING ASEPTIC LOOSENING OF THE PROSTHESIS AND FORCING IT TO UNDERGO A PROSTHETIC REVISION IN 2014, OF INCREASED COMPLEXITY DUE TO THE PRESENCE OF THE TUMOR MASS. MORE TOOLS SINCE THE ONSET OF METALLOSIS AND, EVEN MORE SO, THE DEVELOPMENT OF PSEUDO-TUMOR REPRESENT CLEAR TYPICAL CONSEQUENCES OF METAL-METAL COMBINATIONS. ADDITIONAL INFORMATION RECEIVED ON 12/13/2022: ALLEGEDLY, REPORTED THE ONSET OF LOW-GRADE FEVER, INFECTIOUS CAUSES EXCLUDED. REPORTED GROIN PAIN WITH POAS WEAKNESS FOR ABOUT 1 YEAR. A CLINICAL ANALYSIS WITH ACCEPTANCE DATE OF (B)(6) 2014 SHOWS RESULTS OF P-CHROME 0.4 UG/L AND SG-COBALT 7.7UG/L. CLINICAL RECORDS SHOWED THAT THE DATE OF THE INTERVENTION FOR REVISION SURGERY WAS ON (B)(6) 2014. A MUSCLE-TENDON ULTRASOUND WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP, A CT PELVIS/SACROILIAC WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP AND OTHER STUDIES ARE FOUND FROM PAGES NUMBER 71 TO 77 IN THE FILE "DOC. 05 CARTELLA

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16565555 ↗
• InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM, PRODUCT ID PHA06264, LOT ID 38536091. PROFEMUR® L HIP STEM SIZE 3 HA COATED, PRODUCT ID PHA05506, LOT ID 38563974. PROFEMUR® NECK NEUTRAL SHORT, PRODUCT ID PHA01202, LOT ID 108693562.

  Patient problems: Reaction

  MAUDE report 10337678 ↗
• InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, PATIENT UNDERWENT TOTAL HIP REPLACEMENT. AFTER FOUR YEARS, THE POLY LINER DISENGAGED WHICH CAUSED THE PATIENT TO UNDERGO REVISION SURGERY. ON REVISION IT WAS NOTED ECCENTRIC WEST OF POLY WHICH SUGGESTS POLY WAS NEVER ENGAGED IN SHELL. PATIENT 4 WEEKS AGO COMPLAINED OF A PAIN WHICH IN REVIEW POST OP SUGGESTS LINER FULLY OUT. (B)(4).

  Patient problems: No Information

  MAUDE report 9560325 ↗
• InjuryMay 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION; ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (RIGHT) REVISION NJR NUMBER: (B)(4), PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCT NOT REVISED AND HAS NO COMPLAINT STATED AGAINST THE COMPONENT: PROFEMUR® L HIP STEM SIZE 5 HA COATED, PHA05510, LOT: 38564025. PROFEMUR® NECK A/R VAR/VAL 1 LONG, PHA01224, LOT: 48573065. PROCOTYL L BEADED AND HA COATED CUP SIZE 56MM, PHA06266, LOT: 88644639.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 8656139 ↗