PROCOTYLRecalls & reported problems across all models
Microport Orthopedics Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 149
- Recalls
- 0
We found 15 models of PROCOTYL by Microport Orthopedics Inc. in the FDA's device registry (GUDID). Together they are named in 152 adverse event reports in the FDA's MAUDE database, received between Feb 13, 2018 and Mar 23, 2026 — classified as 149 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (65 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PROCOTYL problems
Device problems
- Device Dislodged or Dislocated65
- Insufficient Device Problem Information47
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available5
- Unstable5
- Break4
- Naturally Worn4
- Noise, Audible4
Patient problems
- Insufficient Information36
- Unspecified Infection35
- No Information24
- Pain24
- Metal Related Pathology13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Loss of Range of Motion7
- Joint Dislocation6
PROCOTYL models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROCOTYL PHA04416Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented35 reports
- PROCOTYL PHA04414Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented23 reports
- PROCOTYL PHA04418Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented19 reports
- PROCOTYL PHA04406Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented12 reports
- PROCOTYL PHA04410Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented12 reports
- PROCOTYL PHA04402Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- PROCOTYL PHA04412Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- PROCOTYL PHA04404Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- PROCOTYL PHA04408Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- PROCOTYL PHA06214Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- PROCOTYL PHA04422Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- PROCOTYL PHA04420Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- PROCOTYL PHA06220Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- PROCOTYL PHA06210PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- PROCOTYL PHA06218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent PROCOTYL adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJan 26, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION/PERIPROSTHETIC FRACTURE. SRNJR NUMBER: (B)(6). SIDE: L GENDER: F.
Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions
MAUDE report 24176563 ↗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 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. SRNJR NUMBER: (B)(6), SIDE: R, GENDER: F. NON-REVISED PRODUCTS: PRODUCT ID: PPPSQH48 PROCOTYL® P PS SHELL QUAD/ LOT NO.: 2007776/ QTY: 1.
Patient problems: Bone Fracture(s)
MAUDE report 22176058 ↗InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
CLINICAL STUDY # (B)(6). PATIENT #(B)(6) REPORTED THE FOLLOWING ADVERSE EVENT: HIP DISLOCATION. DISLOCATION WAS TREATED WITH CLOSE REDUCTION. THIS ADVERSE EVENT DID NOT END IN RE-REVISION SURGERY. NO FURTHER INFORMATION IS PROVIDED DUE TO PRIVACY POLICIES.
Patient problems: Insufficient Information
MAUDE report 21343275 ↗InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION FROM CLINICAL STUDY # (B)(6): PATIENT #65 REPORTED THE FOLLOWING ADVERSE EVENTS: PAIN. THIS ADVERSE EVENT DID NOT END UP IN REVISION SURGERY.
Patient problems: Pain
MAUDE report 21324418 ↗InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION FROM CLINICAL STUDY # (B)(4). PATIENT # (B)(6) REPORTED THE FOLLOWING ADVERSE EVENTS: PAIN AND FUNCTIONAL IMPAIRMENT. THIS ADVERSE EVENT DID NOT END UP IN REVISION SURGERY.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 21324204 ↗InjuryJan 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, AFTER THE INITIAL SURGERY ON (B)(6), THE PATIENT UNDERWENT REHABILITATION INCLUDING GAIT TRAINING, BUT COMPLAINED OF PAIN AND HAD DIFFICULTY WALKING, SO AN X-RAY CONFIRMED DISLOCATION. THE PATIENT WAS ABLE TO MANUALLY REPAIR THE DISLOCATION, BUT LATER DISLOCATED AGAIN, SO A REVISION OPERATION WAS PERFORMED TO REPLACE THE NECK, HEAD, AND BIPOLAR CUP, AND THE PATIENT HAS BEEN STABLE SINCE THEN. DOCTOR'S FINDING: THE PATIENT HAD UNDERGONE REHABILITATION AFTER THE INITIAL OPERATION, BUT REPEATED DISLOCATIONS OCCURRED, SO A REVISION OPERATION WAS PERFORMED. WE WOULD LIKE TO REQUEST AN INVESTIGATION TO SEE IF THE DISLOCATION COULD HAVE BEEN CAUSED BY THE PRODUCT. JAPAN-OC00000588.
Patient problems: Pain
MAUDE report 21242729 ↗InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT UNDERWENT THR ON (B)(6) 2015 LEFT HIP REVISED ON (B)(6) 2019 DUE MULTIPLE HIP DISLOCATION. THE FEMORAL STEM ORIGINALLY USED WAS A PROFEMUR Z CLASSIC SIZE 5 SHORT STRAIGHT NECK AND FEMORAL HEAD WAS A BIOLOX DELTA 28MM S, DOUBLE MOBILITY POLYETHYLENE LINER WAS USED. ONLY THE FEMORAL HEAD AND LINER WERE REVISED THERE IS NO FURTHER DATA ON WHAT DEVICES WERE IMPLANTED AFTER REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21219055 ↗InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.
Patient problems: Insufficient Information
MAUDE report 21209637 ↗InjuryDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT THR ON (B)(6) 2019. REVISED ON (B)(6) 2024 DUE TO AN INFECTION. WASHOUT PERFORMED, HEAD AND LINER REPLACED. AUSTRALIA-C24-597.
Patient problems: Unspecified Infection
MAUDE report 21023264 ↗InjuryDec 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE ARTIFICIAL HEAD WAS DISLOCATED, AND THE BIPOLAR CUP WAS DISLOCATED DURING MANUAL HEALING. AN EMERGENCY CONTEMPLATIVE SURGERY WAS PERFORMED AND THE CUP WAS REPLACED WITH A THA WITH DUAL MOBILITY. PHYSICIAN'S FINDINGS: THE DISLOCATION LED TO A SURGERY THAT WAS VERY BURDENSOME TO THE PATIENT. THE PATIENT WAS ASKED TO INVESTIGATE THE CAUSE AND REPORT BACK. FINDINGS OF THE REPORTER AND STATUS OF RESPONSE: THE RING OF THE BIPOLAR CUP IS FIXED, AND IT IS A PUZZLING CASE AS TO HOW THE PROLAPSE OCCURRED. ONLY CUP AND HEAD RETURN. RELATED MPO PRODUCTS: PRODUCT ID: PRTLS027 PROFEMUR® TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NECK/ LOT NO.: 1802476/ QTY: 1. (B)(4).
Patient problems: Insufficient Information
MAUDE report 20907183 ↗InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, RECENT HIP REVISION DUE TO INFECTION. PRODUCTS IMPLANTED DURING REVISION SURGERY: PRODUCT: PHA06264 ACETABULAR CUP "PROCOTYL® L", LOT: 1979369, QTY: 1 PRODUCT: PHA04660 RIM-LOCK "A-CLASS®" ACETABULAR, LOT: 1949753 QTY: 1 PRODUCT: PHA04412 FEMORAL HEAD BIOLOX DELTA, LOT: 1884368 QTY: 1 AUSTRALIA-C24-515.
Patient problems: Unspecified Infection
MAUDE report 20682949 ↗
Other Microport Orthopedics Inc. products
All Microport Orthopedics Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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