Novation 136-36-53Recalls & 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.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885862024336), received between Oct 22, 2020 and Jun 29, 2026 — classified as 21 injuries, 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (17 reports).
2 FDA recall records name this device's identifier, 2 still open.
14 other recalls cover devices cleared under the same FDA submission (K070479); 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-1729-2022 · 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-2128-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Naturally Worn17
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information4
- Unstable3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Lack of Effect1
- Loss of Osseointegration1
Patient problems
- Osteolysis10
- Pain10
- Failure of Implant9
- Ambulation or Postural Difficulties6
- Discomfort6
- Insufficient Information6
- Scar Tissue4
- Aseptic loosening3
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Unstable; Naturally Worn; Lack of Effect
IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, NINE (9) YEARS LATER, THE PATIENT PRESENTED WITH PAIN, ACHINESS AND LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE WITH A COMPLEX RECONSTRUCTION OF THE LEFT ACETABULUM. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE PATIENT WAS NOTED TO HAVE EXTENSIVE OSTEOLYSIS. THE FEMORAL STEM APPEARED STABLE. THE ACETABULAR CUP WAS MOBILE. THEY NOTED THE SIGNIFICANT DEFORMITY OF THE ACETABULUM WITH FRAGMENTING OF THE ACETABULAR LINER. DUE TO THE PATIENT'S SUPRAACETABULAR DEFECT, IT WAS NOTED TO BE DIFFICULT TO GET A GOOD PURCHASE ON THE NEW IMPLANT WITH THE ELECTED SCREW, HOWEVER, UPON REPOSITIONING THE CUP AND USING A BIGGER SCREW, THE PURCHASE WAS SUCCESSFUL AND NOTED TO HAVE A VERY STABLE FIXATION WITH THE BIGGER SCREW. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT ENDURED JOINT PAIN SWELLING AND STIFFNESS, TISSUE DAMAGE, INSTABILITY, PROSTHESIS WEAR, AND BONE GRAFT.
Patient problems: Aseptic loosening; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema
MAUDE report 25660688 ↗InjuryOct 10, 2024Naturally Worn; Naturally Worn
LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MINIMAL PAIN, OSTEOLYSIS, POLYETHYLENE 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: Osteolysis; Pain; Scar Tissue
MAUDE report 20421034 ↗InjurySep 18, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 76 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
MAUDE report 20246739 ↗InjurySep 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT, INITIAL LEFT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024. THE PATIENT WAS REVISED DUE TO LYSIS. THE SURGEON REMOVED LINER AND HEAD BALLS AND REPLACED LINER AND BALL WITH NEW ONES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN TO ANALYZE. THEY WERE SENT TO PATHOLOGY. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.
Patient problems: Osteolysis
MAUDE report 20165048 ↗InjuryAug 27, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A RIGHT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AND ACETABULAR OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain
MAUDE report 20076187 ↗InjuryJun 20, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A NOVATION GXL DEVICE ON THE LEFT HIP AND THEN APPROXIMATELY 9 YEARS, 4 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING AND REQUIRED REVISION SURGERY. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 19575410 ↗InjuryJun 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A NOVATION GXL DEVICE ON THE LEFT HIP AND THEN APPROXIMATELY 7 YEARS, 5 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19567268 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS 60 Y/O MALE PATIENT'S RIGHT HIP BECAME SORE. HIS HIP WOULD HURT WHEN TRYING TO WALK, LEGS WOULD NOT MORE NORMALLY. SURGEON COULD NOT INITIALLY DETERMINE THE ISSUE. SCHEDULED TO HAVE REVISION SURGERY WITHIN 6 MONTHS.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain
MAUDE report 19525488 ↗InjuryMay 7, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS 61 Y/O MALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 3 YEARS 7 MONTHS POST OP INITIAL SURGERY. POLY USED WAS RECALLED. STEM WAS REVISED TO COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL DOES NOT RELEASE EXPLANTED IMPLANTS.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain
MAUDE report 19259674 ↗InjuryApr 25, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT (CONFIRMED ON X-RAY) PROCEDURE ON (B)(6) 2015 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR. THE STEM WAS RETAINED AND A NEW HEAD IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19182466 ↗InjuryApr 24, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Discomfort; Pain
MAUDE report 19170232 ↗MalfunctionApr 24, 2024Naturally Worn; Naturally Worn
IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Distress; Pain
MAUDE report 19170088 ↗InjuryApr 15, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
EXPERIENCE REPORT - USA PATIENT ID: (B)(6) AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2020. THE PATIENT HAD A REVISION OF THE CUP AND GXL LINER TO COMPETITOR DEVICES ON (B)(6) 2024; REASON NOT REPORTED. THE STEM WAS RETAINED AND A NEW HEAD BALL WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19112162 ↗InjuryAug 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. THE PATIENT IS CURRENTLY SUFFERING THE FOLLOWING COMPLICATIONS, INJURIES: PAIN, DISCOMFORT, AND DIFFICULTY WALKING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain; Insufficient Information; Osteolysis; Pain; Scar Tissue
MAUDE report 17474412 ↗InjuryJun 22, 2023Naturally Worn; Naturally Worn
AS REPORTED VIA LEGAL DOCUMENTATION A 73 Y/O PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6)2023 DUE TO SEVERE PAIN AND OSTEOLYSIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 14-FEB-2023 OP REPORT: POSTOPERATIVE DIAGNOSIS: FAILED RIGHT HIP REPLACEMENT WITH EXTENSIVE OSTEOLYSIS. STERILE DRESSINGS WERE APPLIED AND THE PATIENT RESIDENT WAS TAKEN TO RECOVERY ROOM IN SATISFACTORY CONDITION.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 17182169 ↗InjuryApr 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT HIP REPLACEMENT ON (B)(6) 2014. HE HAD LEFT HIP REVISION ARTHROPLASTY ON (B)(6) 2023, APPROXIMATELY 8 YEARS 3 MONTHS AFTER THEIR INITIAL PROCEDURE, DUE TO SLIGHT INCREASING PAIN AND SUPERIOR ACETABULAR OSTEOLYSIS. THE SURGEON NOTED THAT THE FEMORAL STEM APPEARED TO BE QUITE STABLE WITH NO MOVEMENT. THE CUP WAS REMOVED WITH EASE, AND APPEARED TO HAVE ONLY SPOT WELDING. THE SURGEON ALSO NOTICED VERY LARGE CAVITARY LESION IN THE SUPRA-ACETABULAR AREA AND EXTENDING INTO THE POSTERIOR COLUMN, BUT NO CORTICAL DEFECT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Osteolysis
MAUDE report 16834655 ↗InjuryApr 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PER A REPORT FROM THE LEGAL DEPARTMENT A 56 Y/O MALE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2022 DUE TO SEVERE PAIN. REVISION OP REPORT ((B)(6) 2022). DIAGNOSIS: FAILED LEFT HIP REPLACEMENT (GROSSLY LOOSE CUP). VERY STABLE RECONSTRUCTION. FEMMORAL STEM WAS STABLE AND WELL FIXED - THEREFORE THEY DIDN'T NEED TO BE REVISED. THE CUP WAS GROSSLY LOOSE AND REMOVED EASILY - THERE WAS MODERATE AMOUNT OF OSTEOLYSIS SURROUNDING THE ACETABULAR IMPLANT. MODERATE AMOUNT OF OSTEOLYSIS CHANGES TO THE SOFT TISSUE AS A RESULT OF POLY WEAR. PATIENT WAS REVERSED FROM ANESTHESIA AND SENT TO PACU IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Osteolysis
MAUDE report 16832391 ↗InjuryApr 17, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. REASON FOR THE REVISION WAS NOT REPORTED. THE PATIENT¿S GXL LINER AND CUP WERE REVISED TO COMPETITOR¿S DEVICES AND EXACTECH'S CERAMIC HEAD/SLEEVE. . THE EVENT WAS NOT RELATED TO A BREAKAGE OF A DEVICE. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE SENT TO PATHOLOGY. NO PATIENT INFORMATION, HISTORY, OR COMORBIDITIES REPORTED. NO FURTHER INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Insufficient Information; Osteolysis; Pain; Scar Tissue
MAUDE report 16753856 ↗InjuryFeb 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, THE FEMALE PATIENT HAD A REVISION OF LEFT HIP DUE TO LOOSENING. GXL HEAD SWAPPED, COMPETITOR'S REPLACED CUP SIDE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Aseptic loosening; Failure of Implant
MAUDE report 16418096 ↗InjuryNov 29, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2018, SURGEON REMOVED THE FAILED NOVATION IMPLANT FROM PATIENT AND REPLACED IT WITH ANOTHER NOVATION HIP SYSTEM. THE NOVATION SYSTEM IMPLANTED INTO PATIENT ON (B)(6) 2018 INCLUDED: NOVATION CROWN CUP CONNEXION GXL +5MM LATERALIZED LINER, COCR FEMORAL HEAD, THE NOVATION CROWN CUP CONNEXION GXL +5MM LATERALIZED LINER IMPLANTED INTO PATIENT ON (B)(6) 2018, IS SUBJECT TO AN FDA CLASS 2 RECALL AND POSTED ON THE FDA'S WEBSITE ON SEPTEMBER 9, 2022. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT SURGERY TO REMOVE THE NOVATION WHERE SURGEON FOUND THAT THE NOVATION CAUSED OSTEOLYSIS, THE LINER TO BE LOOSE BECAUSE OF POLY WEAR, MULTIPLE OSTEOLYTIC DEFECTS THAT REQUIRED BONE GRAFTING. ON OR ABOUT (B)(6) 2022, SURGEON REMOVED THE FAILED NOVATION IMPLANT FROM PATIENT AND REPLACED IT WITH ANOTHER HIP DEVICE.
Patient problems: Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain
MAUDE report 15877677 ↗InjuryFeb 28, 2022Naturally Worn; Naturally Worn
AS REPORTED, THIS PATIENT HAD A REVISION DUE TO PREMATURE POLYETHYLENE WEAR AND OSTEOLYSIS. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 13623208 ↗InjuryOct 22, 2020Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 6 ½ YEARS POSTOP THE INITIAL LEFT THA, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE TO CUP MALPOSITION AND POLY WEAR. SURGEON IMPLANTED BIOLOX DELTA OPTION FEMORAL HEAD, 28MM AND A BIOLOX DELTA ADAPTER, 16/18-12/14 +7, 170-50-07. EXACTECH STEM REMAINED INTACT. ALL OTHER IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR¿S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT TO RETURN AS HOSPITAL POLICY.
Patient problems: Failure of Implant
MAUDE report 10721615 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070479. One submission often covers many models, so check the product and lot details in each record.
- Z-2132-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL a
- Z-2126-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner,
- Z-2131-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
- Z-2117-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; 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,
- 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-2116-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
- Z-2121-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;
- Z-2122-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
- Z-2120-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
- Z-2127-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant
- 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-0787-2013 · Nov 5, 2012 · TerminatedExactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replaceme
- Z-0788-2013 · Nov 5, 2012 · TerminatedExactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip r
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- 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 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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