Profemur PHA01202Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI M684PHA012021), received between Feb 23, 2017 and Oct 18, 2024 — classified as 31 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  ALLEGEDLY, THE DATE OF FIRST OPERATION IS TENTATIVELY SET BECAUSE THE INSERTION DATE IS UNKNOWN. THE LOT IS ALSO TENTATIVELY SET BECAUSE THE LOT IS ALSO UNKNOWN. WHEN REV-THA WAS PERFORMED AT ENDA ARTHROPLASTY CENTER DUE TO DEFECTIVE CUP PLACEMENT AND BFH AND NECK WERE REMOVED. WHEN THE JUNCTION BETWEEN THE BFH AND THE NECK WAS REMOVED, IT WAS FOUND TO BE IN A BLACKISH METALLOSIS-LIKE STATE. THERE WAS NO SUCH REACTION ON THE SLIDING SURFACE WITH THE CUP, AND THE REACTION WAS OBSERVED ONLY IN THE AREA MENTIONED ABOVE. ALTHOUGH THERE IS NO EVIDENCE OF PATIENT EFFECTS, WE ANTICIPATE THAT SIMILAR CASES MAY OCCUR IN THE FUTURE WHEN CONSERVE IS REMOVED, SO WE NEED TO REPORT TO PHYSICIANS, INCLUDING PAST CASES. (B)(4).

  Patient problems: Metal Related Pathology

  MAUDE report 20487231 ↗
• InjuryJun 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, ALL WRIGHT MEDICAL COMPONENTS REVISED DUE TO UNKNOWN REASONS. NON-MPO EXPLANTED PRODUCTS: PRODUCT ID: 623-00-44F STYKER TRIDENT X3 POLYETHYLENE INSERT/ LOT. NUMBER: 07613327025422/ QTY:(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19500101 ↗
• InjuryMar 12, 2024Break; Break

  ALLEGEDLY, SUDDEN RUPTURE OF THE NECK CONE WHILE WALKING. BFARM CASE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18887691 ↗
• InjuryNov 7, 2022Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE ? STEM/DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. NON-MPO PRODUCTS: PART ID: 65-6400-50-22 F/M ACET SHELL WITH HA-TCP CALCICOAT - 50MM O.D/ LOT. NUMBER: 60358559/. QTY:1. PART ID: 6415-28-02 ALUMINA INSERT 48-54 X 28/ LOT. NUMBER: 61300387/ QTY:1.

  Patient problems: Metal Related Pathology

  MAUDE report 15743645 ↗
• InjuryMay 12, 2022Output Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LYSIS-STEM/LYSIS-SOCKET/ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. THE CUP, HEAD, STEM AND NECK HAVE BEEN REVISED FROM PATIENT. REVISION NJR NUMBER: (B)(4), SIDE:R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Osteolysis

  MAUDE report 14377749 ↗
• InjuryNov 8, 2021Appropriate Device Problem Term/Code Not Available

  SAE# (B)(4). ALLEGEDLY, THE PATIENT STARTED HAVING LT HIP PAIN 3 WEEKS AFTER SURGERY. MULTIPLE ATTEMPTS TO RELIEF THE PAIN WITH CORTICOSTEROID INJECTIONS INTRA-ARTICULAR WITH NO SUCCESS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR RELEASE OF THE PSOAS TENDON ON (B)(6) 2018. THE PAIN AND WEAKNESS IN THE LEFT THIGH IS STILL PERSISTENT. ADDITIONAL INFORMATION FROM CLINICAL RECEIVED ON 26/10/2021 CONFIRMING THAT COMPONENTS WERE NOT REVISED.

  Patient problems: Pain

  MAUDE report 12771847 ↗
• InjuryOct 13, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12625035 ↗
• InjurySep 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED DUE TO DISLOCATION. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR(R) PROXIMAL BODY PART ID: PPW39102. PRODUCT NAME: PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED PART ID: PPW38026.

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

  MAUDE report 12430959 ↗
• InjuryAug 30, 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 12389244 ↗
• InjuryJan 11, 2021Break; Break

  ALLEGEDLY, SUDDEN FRACTURE OF THE INTERCHANGEABLE NECK OF A TOTAL HIP ENDOPROSTHESIS. WE PERFORMED AN OPERATIVE REVISION OF THE ENTIRE FEMORAL PART OF THE ENDOPROSTHESIS ((B)(6) 2020), AFTER WHICH THE PATIENT IS STILL RECOVERING. JAZMP REFERENCE NUMBER: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 12/24/2020 FROM (B)(6): UPDATING PRODUCT IDS, LOT NUMBERS AND IMPLANT DATE.

  Patient problems: Failure of Implant

  MAUDE report 11148523 ↗
• InjuryJan 5, 2021Malposition of Device

  ALLEGEDLY, CUP WAS IMPROPERLY POSITIONED. LEG LENGTH DIFFERENCE. OUR NECK AND HEAD CAME OUT ALONG W/THE SHELL (W/O CUP CUTTERS). TJO CUP, SCREWS (2), LINER AND HEAD USED WITH OUR NECK. CULTURES TAKEN. BMI 24.8 RIGHT HIP. COMPONENT NOT REVISED: PYRD0004 PROFEMUR RAZ STEM LOT 067426983

  Patient problems: Unequal Limb Length

  MAUDE report 11116311 ↗
• InjuryDec 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 11076797 ↗
• InjuryDec 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 11076742 ↗
• 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 10941256 ↗
• InjuryDec 2, 2020Mechanical Problem; Mechanical Problem

  ALLEGEDLY, PATIENT IMPINGES ON MALPOSITION CUP. CUP WAS CUT OUT AND REPLACED WITH BIOMET CUP AND LINER W/SCREWS. NECK WOULD NOT CAME OUT W/OUR EXTRACTION, OUR HEAD WAS PULLED AND 28MM FROM MPO WAS PUT INTO A BIOMET DUAL MOBILITY HEAD. (RIGHT HIP) COMPONENTS NOT REVISED: PROFEMUR® NECK NEUTRAL / PRODUCT ID: PHA01202 / LOT NO: 065207269, PROFEMUR® Z STEM SIZE 6 STEM / PRODUCT ID: PHA00242 / LOT NO: U0366091.

  Patient problems: Loss of Range of Motion

  MAUDE report 10934792 ↗
• InjuryNov 19, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE NECK-STEM JUNCTION. LEFT HIP COMPONENTS NOT REVISED: DYNASTY® A-CLASS® 36MM 15DG GROUP D CROSSLINKED PO PRODUCT NUMBER: DLXPLD36 LOT BATCH : 1291016120. DYNASTY® BF SHELL 52MM GROUP D PRODUCT NUMBER: DSBFGD52 LOT BATCH : 03098098001. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN PO PRODUCT NUMBER: 18080305 LOT BATCH : 0201048277. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN PO PRODUCT NUMBER: 18080303 LOT BATCH : 089926687.

  Patient problems: No Information

  MAUDE report 10870364 ↗
• InjurySep 29, 2020Corroded; Material Discolored; Corroded; Material Discolored

  ALLEGEDLY, DUE TO DOUBT OF ARMD (ADVERSE REACTION TO METAL DEBRIS) WHICH IS A REVISION BECAUSE IT IS A PSEUDOTUMOR AFTER TOTAL HIP ARTHROPLASTY. THE SURGEON, DR. (B)(6), MENTIONED THAT THIS CAN OCCUR WITH METAL ON METAL DEVICES. THE SURGEON REQUESTED TO MEASURE THE AMOUNT OF IMPLANT WEAR AT THE FOLLOWING JUNCTIONS: CUP + HEAD, HEAD + NECK, AND NECK + STEM. THE INTERFACE BETWEEN THE FEMORAL HEAD AND THE NECK AND THE INTERFACE BETWEEN THE STEM AND NECK HAVE BLACK DISCOLORATION. THE ARTICULATING SURFACE OF THE FEMORAL HEAD AND CUP VISUALLY LOOKS GOOD. (B)(4).

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 10602946 ↗
• InjuryJul 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 50, PPR67250, LOT U0664839. NOYAU "ANCA FIT?"10 DEG. 50*28, PPR67550, LOT U0366975.

  Patient problems: No Information

  MAUDE report 10258072 ↗
• InjuryJul 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 62 PPR67262 LOT S07108479. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11G PPR67606 LOT S07108935. NOYAU "ANCA FIT?"10 DEG. 62*28 PPR67562 LOT S06108481.

  Patient problems: No Information

  MAUDE report 10257641 ↗
• InjuryJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENT NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 50, PPR67250, LOT U0668551. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 12D, PPR67608, LOT T11129538. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, LOT U09112683.

  Patient problems: No Information

  MAUDE report 10254687 ↗
• InjuryJul 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENT NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 46, PPR67246, LOT: R0793475.3. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11D, PPR67604, LOT: R1097252<1 INSERT CERAM "ANCA FIT?" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, LOT: S01100847X1.

  Patient problems: No Information

  MAUDE report 10230312 ↗
• InjuryMay 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.

  Patient problems: No Information

  MAUDE report 10085260 ↗
• InjuryApr 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED : COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 PPR67352, LOT S05105284. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE PPR67510, LOT S05107050. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11D PPR67604, LOT S05104470.

  Patient problems: Fibrosis

  MAUDE report 9983419 ↗
• InjuryApr 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENTS NOT REVISED: COTYLE "PROCOTYL® Z" REVETU TP TAILLE 48 G1 PHA05004, LOT W04288403. TIGE "JVC" A/COLLERETTE- A/CIMENT TAILLE 3 (POLIE PPV93006, LOT V03137006. INSERT CERAMIQUE 18° 28/37G T 28 GROUPE 1 BIOLOX FORTE PHA02046, LOT V04170802.

  Patient problems: No Information

  MAUDE report 9916094 ↗
• InjuryApr 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 PPR67254, LOT U0764842. TIGE "JVC" A/COLLERETTE- A/CIMENT TAILLE 2 (POLIE PPV93004, LOT U0880624. NOYAU "ANCA FIT?"10 DEG. 54*28 PPR67554, LOT U0768596.

  Patient problems: No Information

  MAUDE report 9915708 ↗