PROCOTYL PHA04414Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI M684PHA044141), received between May 15, 2020 and Jun 25, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.

• InjuryJun 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L GENDER: F NON REVISED PRODUCTS: PRODUCT ID: PPPSQH50, PROCOTYL® P PS SHELL QUAD/ LOT NO.: 2007793 / QTY: 1; PRODUCT ID: PRTLE024, PROFEMUR TL CLASSIC EXTENDED OFFSET FIXED NECK SIZE 4/ LOT NO.: 1939160 / QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 19608740 ↗
• InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT IS GOING THROUGH PAIN AND WAS ADVISED IT COULD BE TOXICITY PAIN PERHAPS DUE TO THE METALS/METALS IN THE IMPLANTS SHE HAS.

  Patient problems: Pain

  MAUDE report 19520149 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT SUFFERED PAIN, INFECTION, LOSS OF MOBILITY AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19034072 ↗
• InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, INFECTION/ UNEXPLAINED PAIN. SIDE: L. REVISION NJR: 4975433. GENDER: M EXPLANTED: ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18798162 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, DISLOCATION/SUBLUXATION. SIDE: L. REVISION NJR: 2865282. GENDER: F. EXPLANTED: FEMORAL STEM.

  Patient problems: Insufficient Information

  MAUDE report 18793397 ↗
• InjuryFeb 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT EXPERIENCED DISLOCATION, LOSS OF MOBILITY, SWELLING, ADVERSE TISSUE REACTION, AND PAIN DUE TO METAL-ON-METAL COMPONENTS.

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

  MAUDE report 16278064 ↗
• InjurySep 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT LEFT THR ON (B)(6) 2017. REVISED ON (B)(6) 2022 DUE TO DISLOCATION. INITIALLY SURGEON REPLACED HEAD, THEN CUP, THEN STEM UNTIL HIP EVENTUALLY BECAME STABLE. ALL COMPONENTS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S SYSTEM. (B)(6) - (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15414326 ↗
• InjuryJun 20, 2022Unstable; Unstable

  ALLEGEDLY, REVISED FOR INSTABILITY TO LARGER HEAD. THE FOLLOWING PRODUCTS WERE NOT REVISED: PRODUCT ID: DBFPGG62 DYNASTY BIOFOAM SHELL 62MM, LOT: 1700901, QTY: 1; PRODUCT ID: 18080302 CANCELLOUS SELF-TAPPING BONE SCREW 6.5X2.5, LOT: 1805477, QTY: 1; PRODUCT ID: PRTLEL30 PROFEMUR TL CLASSIC 10 VARUS LONG NECK, LOT: 1873812, QTY: 1.

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

  MAUDE report 14748819 ↗
• InjuryMay 30, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING MODERATE PAIN, AND THE IMPLANTS WERE REVISED FOR METALLOSIS, ACCORDING TO THE SURGEON. THE MODULAR NECK TRUNNION (FITTING IN TO THE STEM POCKET) WAS NOTICEABLY "BLACKENED". ALL IMPLANTS WERE REMOVED, AND REPLACED WITH A THR CEMENT SPACER. UNFORTUNATELY IT WASN'T POSSIBLE TO REMOVE THE LINER FROM THE PROCOTYL L SHELL, SO I CANT PROVIDE THE LOT NUMBER FOR THE BIOLOX LINER. ADDITIONAL INFORMATION RECEIVED ON 05/13/2022 FROM NJR: NJR ADVISED THAT THE PATIENT WAS REVIEWED DUE TO INFECTION AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. REVISION NJR NUMBER: (B)(4), SITE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 14543100 ↗
• InjuryMay 10, 2022Patient-Device Incompatibility

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT:PROFEMUR® L HIP STEM SIZE 5 HA COATED PRODUCT ID: PHA05510, LOT#: 1674917, QTY:1. PRODUCT:PROFEMUR® NECK A/R 8DGLONG COBALT CHROME PRODUCT ID: PHAC1234, LOT#: 1830376 .QTY:1 REVISION NJR NUMBER: (B)(4).SIDE: L. PRIMARY ASA: P2 MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology

  MAUDE report 14348509 ↗
• InjuryFeb 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

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

  MAUDE report 13414998 ↗
• InjuryDec 15, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT ? STEM/MALALIGNMENT ? SOCKET/UNEXPLAINED PAIN. REVISION NJR NUMBER: (B)(6). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PHAC1214 PROFEMUR® NECK A/R VAR/VAL 2 LONG COBALT CHROME, LOT#1683882, QTY:1. PHA05512 PROFEMUR® L HIP STEM SIZE 6 HA COATED, LOT#1712402, QTY:1.

  Patient problems: Pain

  MAUDE report 13009152 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: (B)(4). SIDE:R PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 12447731 ↗
• InjurySep 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION. THE PATIENT WAS IMPLANTED WITH A NON-MPO SHELL, LINER, AND FEMORAL HEAD. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR(R) PROXIMAL BODY PART ID: PPW39102. PRODUCT NAME: PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED PART ID: PPW38026. ADDITIONAL INFORMATION RECEIVED ON 09/02/2021, FROM INITIAL REPORTER (B)(6). SITE STATED THEY USED A NON-MPO FEMORAL HEAD. THEREFORE, THE INCIDENT WITH PART NAME FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S AND PART ID: PHA04414, NEEDS TO BE VOIDED.

  Patient problems: Insufficient Information

  MAUDE report 12430956 ↗
• InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12393813 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12388454 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, CUP, LINER, SCREW, HEAD EXTRACTED IN FAVOR OF A STRYKER REVISION CUP/CONSTRAINED LINER AND A MP 22 MM HEAD. ADDITIONAL INFORMATION WAS RECEIVED ON 03/17/2021 FROM DISTRIBUTOR: INCIDENT FORM CONTAINING SUBSTANTIAL INFORMATION, ALSO ON THIS DAY, REASON FOR REVISION. ALLEGEDLY, THE PATIENT HAD DISLOCATED SEVERAL TIMES.

  Patient problems: Joint Dislocation

  MAUDE report 11589468 ↗
• InjuryMar 24, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT REVISED FOR INSTABILITY WITH A DUAL MOBILITY CUP. COMPONENT NOT REVISED: PROFEMUR RENAISSANCE STEM LONG PRODUCT ID: PLLES013 LOT NO.: 1617782.

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

  MAUDE report 11562934 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION AND SUBLUXATION. REVISION NJR NUMBER: (B)(6). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROFEMUR® L HIP STEM SIZE 3 HA COATED PRODUCT NUMBER: PHA05506 LOT NUMBER: 1442169. PROFEMUR® NECK 15DG VAR/VAL SHORT PRODUCT NUMBER : PHA01264 LOT NUMBER: 1393921.

  Patient problems: No Information

  MAUDE report 10657237 ↗
• InjurySep 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DEEP WOUND INFECTION. LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 10503362 ↗
• InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING SOCKET AND PAIN. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROFEMUR® L HIP STEM SIZE 3 HA COATED PRODUCT ID PHA05506 LOT ID 411326623. PROFEMUR® NECK 15DG VAR/VAL SHORT PRODUCT ID PHA01264 LOT ID 78590490.

  Patient problems: Pain

  MAUDE report 10339285 ↗
• InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4408635. SIDE:L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Unspecified Infection

  MAUDE report 10337580 ↗
• InjuryMay 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COTYLE AND LINER ARE NOT MPO PRODUCTS. COMPONENTS NOT REVISED: PROFEMUR® L HIP STEM SIZE 8 HA COATED, PHA05516, LOT W10359386.

  Patient problems: No Information

  MAUDE report 10061103 ↗