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Novation 130-32-51Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Novation (184)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Exactech Novation hip implant is a hip joint replacement with a plastic liner. Its 154 reports mostly describe plastic liner wear, bone loss around the implant, and pain, with some patients needing another surgery. The reports include no deaths and 146 injuries, and 8 are malfunctions. Its 2 recalls are both open and concern premature wear of the implant.

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
156
Deaths reported
0
Injuries reported
148
Recalls naming it
2

Summary

The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 10885862207074), received between Jun 8, 2020 and Sep 18, 2026 — classified as 148 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (145 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 other recalls cover devices cleared under the same FDA submission (K121392); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 4 reportsDec 2023: 3 reportsJan 2024: 1 reportsFeb 2024: 4 reportsMar 2024: 3 reportsApr 2024: 2 reportsMay 2024: 5 reportsJun 2024: 9 reportsJul 2024: 6 reportsAug 2024: 9 reportsSep 2024: 9 reportsOct 2024: 5 reportsNov 2024: 2 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 5 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 11, 2022Class IIOpen, Classified

    Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

    Z-1732-2022 · Root cause: Process control · Recall details · FDA record ↗

  2. Jun 29, 2021Class IIOpen, Classified

    Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

    Z-2117-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn145
  • Adverse Event Without Identified Device or Use Problem22
  • Insufficient Device Problem Information16
  • Device Dislodged or Dislocated4
  • Loosening of Implant Not Related to Bone-Ingrowth3
  • Unstable3
  • Crack1
  • Fracture1

Patient problems

  • Failure of Implant82
  • Osteolysis75
  • Pain56
  • Insufficient Information38
  • Discomfort16
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
  • Joint Laxity15
  • Ambulation or Postural Difficulties14

Recent adverse event reports

The 25 most recent of 156 reports, in the reporter's own words as published by the FDA.

  • InjurySep 18, 2026Naturally Worn

    It was reported that the patient underwent a hip replacement. Subsequently, the patient experienced persistent hip pain, inflammation, and limited mobility. Additional symptoms included noises, clicking sensations, and a feeling of instability while walking. Radiographic evaluation reportedly confirmed loosening and osteolysis. Due to these findings, the treating orthopedic surgeon recommended revision surgery to remove and replace the affected implant components. The outcome of the revision procedure, if performed, was not reported. No further information is available.

    Patient problems: Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain

    MAUDE report 50820557 ↗
  • InjurySep 14, 2026Naturally Worn

    Patient problems: Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain

    MAUDE report 50757250 ↗
  • InjuryJun 12, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Osteolysis

    MAUDE report 25486078 ↗
  • InjuryApr 21, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 24943224 ↗
  • InjuryMar 24, 2026Naturally Worn

    IT WAS REPORTED A FEMALE PATIENT, WHO HAD A RIGHT THA, REPORTED EARLY WEAR OF PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE AND WAS ADMITTED TO THE HOSPITAL AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

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

    MAUDE report 24681372 ↗
  • InjuryMar 19, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 24643108 ↗
  • InjuryMar 16, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information; Osteolysis

    MAUDE report 24610531 ↗
  • InjuryMar 16, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH PREMATURE WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information; Osteolysis

    MAUDE report 24603712 ↗
  • InjuryMar 11, 2026Naturally Worn

    IT WAS REPORTED THAT A 65 YO FEMALE PATIENT, WHO HAD AN INITIAL LEFT THA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS POST THE INITIAL PROCEDURE. PE WEAR + MICROPARTICLE DISEASE, PAIN DURING HIP ROTATIONS REPORTED. THE CUP WITH A MODEL G7 50 PROSTHESIS, WITH A CERAMIC-CERAMIC 32 L FRICTION PAIR WERE REPLACED. THE CYSTIC AREAS WERE FILLED WITH BONE GRAFT. INTRAOPERATIVE CULTURES ARE NEGATIVE. HAVING FOLLOWED A SATISFACTORY EVOLUTION, HE BEGAN AMBULATION 48 HOURS AFTER SURGERY WITHOUT COMPLICATIONS AND WAS DISCHARGED. FAVORABLE EVOLUTION, SATISFACTORY FROM AN ORTHOPEDIC STANDPOINT; AMBULATION WITH TWO CRUTCHES INDICATED. NO FURTHER INFORMATION. ADDITIONAL INFORMATION RECEIVED 2/20/2026: INVOICE RELATED TO THE SURGERY PERFORMED ON (B)(6) 2019 (MEDICAL RECORD NO. (B)(6) / CIC NO. (B)(6), INCLUDING THE PRODUCT REFERENCE NUMBERS AND THE CORRESPONDING LOT/SERIAL NUMBERS. IMPLANT REGISTER AND TRACEABILITY SHEET FOR THE REVISION SURGERY ON (B)(6) 2025 (MEDICAL RECORD NO. (B)(6) / CIC NO. (B)(6), INCLUDING THE IMPLANT LABELS FOR THE IMPLANTED MATERIAL. REF B076.1713.000.00 CERAMIC HEAD 32MM L 12/14 CONE SN: (B)(6). MATERIAL: BIO CERAMIC. SUSPECT DEVICE(S): 130-32-51 - NV GXL LINER N

    Patient problems: Osteolysis; Pain

    MAUDE report 24573585 ↗
  • InjuryFeb 26, 2026Naturally Worn

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCING DISCOMFORT. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD PREMATURE WEAR. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Discomfort

    MAUDE report 24455718 ↗
  • InjuryJan 21, 2026Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED VIA A CLINICAL SHOULDER STUDY, THAT 76 YO MALE PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH PAIN. THERE WAS RADIOGRAPHIC EVIDENCE OF HUMERAL COMPONENT LOOSENING. THE STANDARD HUMERAL STEM, TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER WERE REMOVED. THE OUTCOME INDICATES RESOLVED. DEFINITELY RELATED TO DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. NO FURTHER INFORMATION.

    Patient problems: Aseptic loosening; Pain

    MAUDE report 24136823 ↗
  • InjuryJun 5, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT, WHO HAD A HIP IMPLANTED, WAS REVISED TO A 140-32-51 CC INLAY VITAMIN E NEUTRAL, Ø 32, GR.1 B135501. NO FURTHER INFORMATION KNOWN AT THIS TIME.

    Patient problems: Cyst(s); Discomfort; Insufficient Information; Osteolysis; Pain

    MAUDE report 22155205 ↗
  • InjuryJan 15, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 21161742 ↗
  • InjuryJan 10, 2025Naturally Worn; Naturally Worn

    AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL HIP REPLACEMENT, THE PATIENT WAS REVISED DUE TO POSSIBLE FEMORAL LOOSENING. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 21127425 ↗
  • InjuryDec 31, 2024Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 4 YEARS POST INITIAL TOTAL HIP ARTHROPLASTY (THA), AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A SLIGHT DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 1, 32 MM I.D). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE CUP BED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE REPLACEMENT OF THE PROSTHESIS HEAD.

    Patient problems: Cyst(s); Osteolysis

    MAUDE report 21047769 ↗
  • InjuryNov 6, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 20626062 ↗
  • InjuryNov 1, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA CASE: (B)(4). LH REV IS ASSOCIATED WITH THIS CASE. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022. IT WAS REPORTED THAT APPROXIMATELY 118 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 20591681 ↗
  • InjuryOct 28, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 1, 32 MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE CUP BED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

    Patient problems: Osteolysis

    MAUDE report 20552129 ↗
  • InjuryOct 17, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information; Joint Dislocation

    MAUDE report 20474834 ↗
  • InjuryOct 7, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA (MDL NO. (B)(4) CASE- (B)(4) RH IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, POLYETHYLENE WEAR, SOFT TISSUE DAMAGE, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING; DAILY PAIN AND DISCOMFORT, LIMITED HER ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; OSTEOLYSIS, ONGOING MEDICAL CARE. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

    Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain

    MAUDE report 20390576 ↗
  • InjuryOct 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

    LEGAL CASE: (B)(4). CASE: (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, POLYETHYLENE WEAR, SOFT TISSUE DAMAGE, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING; DAILY PAIN AND DISCOMFORT, LIMITED HER ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; OSTEOLYSIS, ONGOING MEDICAL CARE. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. AT THE TIME OF LEGAL NOTIFICATION, A REVISION PROCEDURE HAD NOT BEEN PERFORMED. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

    Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain

    MAUDE report 20388914 ↗
  • InjuryOct 1, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, DEBRIS, FEMORAL HEAD WEAR, ACETABULAR LINER WEAR, OSTEOLYTIC CAVITIES, LOSS OF MOBILITY AND JOINT PAIN AND SWELLING. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information; Osteolysis; Pain; Swelling/ Edema; Synovitis

    MAUDE report 20344450 ↗
  • InjurySep 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ECCENTRIC POLYETHYLENE WEAR AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Osteolysis

    MAUDE report 20293067 ↗
  • InjurySep 17, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS MALE PATIENT'S HIP WAS REVISED APPROXIMATELY 3 YEARS 9 MONTHS POST OP. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND SMALL OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024 TO A VIT E-HARDENED SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 1, 32 MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED AND THE PROSTHESIS HEAD WAS REPLACED.

    Patient problems: Osteolysis

    MAUDE report 20242390 ↗
  • InjurySep 11, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Osteolysis; Pain; Scar Tissue

    MAUDE report 20192728 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121392. One submission often covers many models, so check the product and lot details in each record.

  • Z-2129-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant
  • Z-2119-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component
  • Z-2123-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
  • Z-2118-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
  • Z-2133-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,

Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices

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Sources and updates

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