PROCOTYL PHA04416Recalls & reported problems
Microport Orthopedics Inc. · FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M · Class 2 · Implant
Quick summary
This MicroPort Orthopedics hip implant component is a ceramic femoral head used in total hip replacement. The 35 adverse event reports mostly describe the hip coming dislocated or loosening, along with pain, reduced movement, and infection that led to revision surgery in several patients; 34 reports describe injuries and no deaths. Many reports give too little detail to identify a specific device problem. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI M684PHA044161), received between May 30, 2019 and Mar 23, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information13
- Device Dislodged or Dislocated11
- Noise, Audible3
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information11
- Unspecified Infection11
- No Information8
- Pain4
- Loss of Range of Motion2
- Hypersensitivity/Allergic reaction1
- Metal Related Pathology1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2026Insufficient Device Problem Information
ALLEGEDLY, INFECTION WITH THE SERRATIA MARCESCENS BACTERIA. HOSPITAL SUSPECTS THAT THE ICE AND/OR THE BAGS CONTAINING IT, USED TO PREVENT POST-OPERATIVE SWALLOWING, MAY HAVE BEEN CONTAMINATED. THE HOSPITAL ALSO TESTED A THIRD PATIENT WHO HAD USED MPO PRODUCTS. THAT THIRD PATIENT'S EXAM WAS NEGATIVE, SO THEY DISCARDED MPO PRODUCTS FROM BEING THE CAUSE OF THE INFECTION. PREVIOUSLY HOSPITALIZED AT HOSPITAL (B)(6) ((B)(6) 2025) AND HOSPITAL (B)(6) ((B)(6) 2025).
Patient problems: Unspecified Infection
MAUDE report 24664845 ↗InjuryJan 28, 2026Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 24200261 ↗InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: M. OTHER LEGAL MANUFACTURER: PRODUCT ID: 321.05.936 TRINITY LINER (HXLPE) 036MM NEUTRAL 4MM EPW TAPER SIZE 5 CORIN.
Patient problems: Unspecified Infection
MAUDE report 22999145 ↗InjuryJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6), SIDE: L, GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 22323986 ↗InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO OTHER. SRNJR NUMBER: (B)(6). SIDE: L GENDER: M
Patient problems: Insufficient Information
MAUDE report 19586544 ↗InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, INFECTION. SIDE: L. REVISION NJR: 4395938. GENDER: M. EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.
Patient problems: Unspecified Infection
MAUDE report 18798565 ↗InjuryFeb 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, DISLOCATION/SUBLUXATION / OTHER SIDE: L REVISION NJR: (B)(4). GENDER: M EXPLANTED: ACETABULAR CUP.
Patient problems: Insufficient Information
MAUDE report 18797863 ↗InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, UNKNOWN FAILURE SIDE: L REVISION NJR: 4171106. GENDER: M EXPLANTED: FEMORAL STEM, MODULAR HEAD.
Patient problems: Insufficient Information
MAUDE report 18793133 ↗InjuryFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, LOOSENING - SOCKET/DISLOCATION/SUBLUXATION/DISSOCIATION OF LINER SIDE: R. REVISION NJR: GENDER: M. EXPLANTED: ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.
Patient problems: Insufficient Information
MAUDE report 18759892 ↗InjuryJan 8, 2024Break; Break
ALLEGEDLY, BREAKAGE OF THE HEAD AFTER MOVEMENT OF PATIENT.
Patient problems: Insufficient Information; Loss of Range of Motion; Pain
MAUDE report 18466577 ↗InjuryJun 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE PATIENT WHO UNDERWENT TOTAL HIP REPLACEMENT PERFORMED ELSEWHERE AND HAS DEVELOPED RECURRENT DISLOCATIONS OF THE HIP AND HAS HAD 3 DISLOCATIONS SINCE (B)(6)2022. SHE HAS FAILED NONOPERATIVE MANAGEMENT CONSISTING OF ACTIVITY MODIFICATION, PHYSICAL THERAPY AND EDUCATION.
Patient problems: Insufficient Information
MAUDE report 17108061 ↗MalfunctionFeb 27, 2023Packaging Problem; Packaging Problem
ALLEGEDLY, PACKAGING AND CONTENT DIDN'T MATCH... INSIDE THE 36MM MEDIUM HEAD PACKAGING, WAS AN 28MM SMALL HEAD AS CONTENT. WE OPENED ANOTHER ONE (PHA04416 WITH LOT 1920149) FOR THIS SURGERY, WHICH WAS RIGHT LABELED AND PACKED. THIS EVENT HAS BEEN A TRIGGER FOR THE CREATION OF A DPRA. DUE TO THIS DPRA IT IS CONSIDERED THAT THIS INCIDENT SHOULD BE A REPORTABLE EVENT.
Patient problems: Insufficient Information
MAUDE report 16443283 ↗InjurySep 26, 2022Patient-Device Incompatibility; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT RECEIVED A LEFT HIP PROSTHESIS ON (B)(6) 2015 AND A RIGHT HIP PROSTHESIS ON (B)(6) 2016, BOTH WERE PERFORMED AT HOSPITAL (B)(6). DURING 2017, PATIENT SUFFERED HIS FIRST HIP DISLOCATION. THEN, DURING 2018, PATIENT SUFFERED A SECOND DISLOCATION. ON THE SAME YEAR, 2018, THE PATIENT WAS DIAGNOSED WITH A PSEUDOTUMOR. PATIENT SUFFERED AN ADVERSE REACTION TO THE METAL COMING FROM THE IMPLANTED DEVICES. IT IS TO NOTE THAT PATIENT IS ALLERGIC TO COBALT AND THAT THE PROSTHESIS REMAINS IMPLANTED IN PATIENT. REPORTER STATED ON INITIAL EMAIL NOTIFICATION THAT THIS WAS A CASE IMPLANTED IN 2015 WITH CONFIRMED METALLOSIS IN POSTERIOR ANALYSIS.
Patient problems: Metal Related Pathology
MAUDE report 15487371 ↗InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(4). ADDITIONAL INFORMATION: ALLEGEDLY, AS REPORTED FROM (B)(6) REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15351227 ↗InjuryMar 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PT. DISLOCATED. REVISED CUP (REPOSITIONED). PRODUCT NO REVISED: PRODUCT ID: PHAPE242 PROFEMUR Z 6 LONG VARUS STEM, LOT: 1906933, QTY: 1.
Patient problems: Insufficient Information
MAUDE report 13969151 ↗InjuryOct 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(4), SIDE:R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING, UNREVISED COMPONENT: PARTID: PHA05508--LOT: 59830349-- PROFEMUR® L HIP STEM SIZE 4 HA COATED--QTY:1 (NOT CAPTURED).
Patient problems: Insufficient Information
MAUDE report 12637217 ↗InjurySep 23, 2021Noise, Audible; Noise, Audible
ALLEGEDLY, PATIENT PRESENTED WITH PAIN AND SQUEAKING SOUND COMING FROM HIP. REQUIRED CUP, LINER AND HEAD REMOVAL AND REPLACEMENT. REVISED ON (B)(6) 2021 DUE TO WORN LINER.
Patient problems: Pain
MAUDE report 12520040 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, PATIENT HAD AN ALLERGIC REACTION DUE TO IMPLANTATION OF HIP SYSTEM.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 12438187 ↗InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, A PATIENT WAS REVISED FOR CUP LOOSENING AND DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12402065 ↗InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, PATIENT UNDERWENT L THR ON (B)(6) 2021. REVISED ON (B)(6) 2021 DUE TO INFECTION. WASHOUT PERFORMED, LINER AND HEAD REPLACED. (B)(4).
Patient problems: Unspecified Infection
MAUDE report 12132655 ↗InjuryJun 25, 2021Loose or Intermittent Connection
SAE # (B)(4): ALLEGEDLY, THE PATIENT HAD A LUXATION OF THE RIGHT HIP WITH PERIPROSTHETIC FRACTURE. JOINT REDUCTION PERFORMED ON (B)(6) 2017. SAE # (B)(4): ALLEGEDLY, PATIENT SAT ON THE SOFA. WHEN LIFTING THE RIGHT LEG, THE HIP LUXATED. RECOVERED AFTER REMOVING HEAD AND MODULAR NECK OF THE RIGHT HIP. (B)(6) CASE NUMBER: (B)(4).
Patient problems: Insufficient Information
MAUDE report 12071201 ↗InjuryMay 12, 2021Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible
ALLEGEDLY, PATIENT WAS IN KITCHEN AND FELT A "POP" AND THEN THE JOINT SQUEAKED. X-RAYS INDICATED A SUSPECTED CRACKED POLY LINER. DURING REVISION IT WAS SEEM THAT THE POLY WAS INTACT BUT THE PATIENT WAS IMPINGING AND WEARING THE RIM OF THE LINER AND CUP. PLEASE SEE ATTACHED PHOTOS. CUP WAS REVISED AND A BIOLOX DELTA OPTION HEAD WAS IMPLANTED. POSSIBLY PATIENT WAS EXTERNALLY ROTATING EXCESSIVELY LEADING TO IMPINGEMENT AND ECCENTRIC WEAR. PRODUCTS NOT REVISED: PROFEMUR PLASMA Z CLASSIC FEMORAL STEM W/LONG NECK SIZE 7 VARUS 8 DEGREE / PRODUCT ID: PHAPE244 / LOT NUMBER: 0798768751605863.
Patient problems: Loss of Range of Motion
MAUDE report 11812488 ↗InjuryMar 2, 2021Loosening of Implant Not Related to Bone-Ingrowth
ALLEGEDLY, CUP LOOSENED AND CAUSING WEIGHT BEARING PAIN. BLOOD PATHOLOGY INDICATED INFECTION. ALL PROSTHESIS REMOVED (ETO WAS PREFORMED ON FEMORAL STEM) AND ANTIBIOTIC CEMENT SPACER IMPLANTED. PHOTO'S OF X-RAY AND REMOVED IMPLANTS WERE PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 11398242 ↗InjuryDec 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: (B)(4), SIDE:L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 10941175 ↗InjuryNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING STEM; INFECTION; LYSIS STEM; PAIN REVISION NJR NUMBER: (B)(4); SIDE:L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING; MHRA REFERENCE NO: (B)(4).
Patient problems: Pain; Unspecified Infection
MAUDE report 10777363 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.