PROCOTYL PHA04418Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M684PHA044181), received between Feb 13, 2018 and Jun 28, 2024 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F. NON MPO REVISED PRODUCTS: PRODUCT ID: PT106056, REGEN/RNGLC+ MULTI 56MM SZ 24. LOT: UNKNOWN. QTY: 1. PRODUCT ID: EP043654, E1 ABT STANDARD ACETAB LINER 36/54MM (SZ 24). LOT: UNKNOWN. QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 19638743 ↗
• InjuryApr 29, 2024Break; Corroded; Break; Corroded

  ALLEGEDLY, REVISION SURGERY WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE HEAD-NECK JUNCTION AND NECK-STEM JUNCTION. THE PATIENT EXPERIENCE FRACTURE AT THE STEM AND MODULAR NECK JUNCTION, METALLOSIS, TISSUE REACTION, PSEUDOTUMOR, PAIN, LOSS OF MOBILITY AND CORROSION.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 19203377 ↗
• InjuryFeb 27, 2024Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  ALLEGEDLY, MALALIGNMENT ? SOCKET/DISLOCATION/SUBLUXATION. SIDE: L. REVISION NJR: (B)(6). GENDER: M. EXPLANTED: ACETABULAR CUP.

  Patient problems: Insufficient Information

  MAUDE report 18792361 ↗
• InjuryNov 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT INFECTED WITH STAPHYLOCOCCUS AUREUS.

  Patient problems: Unspecified Infection

  MAUDE report 18120753 ↗
• InjuryAug 21, 2023Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  ALLEGEDLY, AN INFO RECEIVED FROM LOCAL SALES REP THAT A CURIOUS FREQUENCY OF REVISIONS (TWO DONE EARLY 2023, AND OTHER TWO SCHEDULED FOR NEXT (B)(6) 2023 IN TWO HOSPITALS) OF DYNASTY A-CLASS LINERS DUE TO HIGH WEAR RATE AFTER 6 TO 8 YRS POST OP. NO ENOUGH INFO AVAILABLE REGARDING THE ALREADY-DONE REVISIONS, WE WILL COLLECT INFO AND EXPLANTS FROM THE SCHEDULED ONES. ADDITIONAL INFORMATION RECEIVED ON 07/18/2023: ALLEGEDLY, FROM MY EARLY INVESTIGATION OF THE THIRD LINER EXPLANT, IT SEEMED MUCH MORE A LOCKING MECHANISM ISSUE THAN WEAR, AS THE LINER DOES NOT LOOK THINNED OUT, AND THE FEMORAL HEAD SHOWED A BLACK MARK DEMONSTRATING FRICTION AGAINST THE CUP, WHICH MIGHT MEAN THAT THE LINER FLIPPED INTO THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 17584312 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: 4537592. SIDE: L. PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Insufficient Information

  MAUDE report 16725677 ↗
• InjuryFeb 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, HEAD REVISED FOR UNKNOWN REASONS. MPO IMPLANTED DEVICE: PRODUCT ID: PHA04416 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M/ LOT NUMBER: 1715181/ QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 16386160 ↗
• InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT DISLOCATED 1-2 WEEKS AFTER SURGERY THE SOFT TISSUES WERE VERY LAX REQUIRED ZIMMER CONSTRAINED.

  Patient problems: Joint Dislocation

  MAUDE report 15788704 ↗
• InjuryNov 7, 2022Particulates

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Metal Related Pathology

  MAUDE report 15743382 ↗
• InjuryOct 19, 2022Particulates

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology

  MAUDE report 15633157 ↗
• InjurySep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® R GRIT BLASTED PROX BODY SMALL PART ID: PPW39102. PRODUCT NAME: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED PART ID: PPW38046.

  Patient problems: Insufficient Information

  MAUDE report 12422197 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12389097 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT DISLOCATED THE DAY AFTER SURGERY. THE SURGEON FELT THAT THE REASON FOR THE DISLOCATION WAS A "LACK OF TENSION", OR OFFSET. THIS WAS RESOLVED WITH A BIGGER STEM, CREATING MORE OFFSET, AND USING THE VARUS OPTION, PLUS A LONGER HEAD. THE SURGEON PUTS THIS DOWN TO SURGEON ERROR. ALSO, THE DIGITAL TEMPLATING SYSTEM WAS NOT AVAILABLE BEFORE THE OPERATION WITH FURTHER COMPLICATED MATTERS. ADDITIONAL INFORMATION RECEIVED ON 11/16/2020: ADDING COMPONENTS NOT REVISED, PATIENT INFORMATION AND INCIDENT CODE: COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM / PRODUCT ID: PHA06264 / LOT NO: 1802480. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP E / PRODUCT ID: PHA04510 / LOT NO: 1819068.

  Patient problems: No Information

  MAUDE report 10911459 ↗
• InjuryOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION , SUBLUXATION AND MALALIGNMENT STEM. REVISION NJR NUMBER: 4502611. SIDE:R . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. NO INFORMATION PROVIDED FOR STEM. ADDITIONAL INFORMATION RECEIVED ON 10/08/2020 FROM (B)(6): ADDING A NEW INCIDENT FOR THE STEM WITH PARTIAL PRODUCT INFORMATION ADDITIONAL INFORMATION RECEIVED ON 11/09/2020 FROM (B)(6) : ADDING STEM PRODUCT NUMBER AND LOT BATCH. MHRA REFERENCE NO: (B)(4).

  Patient problems: No Information

  MAUDE report 10765453 ↗
• InjuryAug 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 8927772 ↗
• MalfunctionAug 1, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ALLEGEDLY, PATIENT WAS REVISED DUE TO SEPTIC LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 8852276 ↗
• InjuryAug 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN WITHOUT LOOSENING. PRODUCT NOT REVISED: ACETABULAR CUP "PROCOTYL® L" BEADED COATED S.54 GROUP E, CATALOG # PHA0-6214, LOT # 10746483501, QTY 1. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP E, CATALOG # PHA04510, LOT # X10473186, QTY 1.

  Patient problems: Pain

  MAUDE report 8850329 ↗
• InjuryMay 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION (RIGHT). REVISION NJR NUMBER: (B)(6). PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 8656100 ↗
• InjuryFeb 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. ALL COMPONENTS REVISED.

  Patient problems: No Information

  MAUDE report 7266412 ↗