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
Recalls naming this device
- 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 ↗
- 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, ClassifiedExactech 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, ClassifiedExactech 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, ClassifiedExactech 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, ClassifiedExactech 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, ClassifiedExactech 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
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
- Novation 132-40-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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