Novation 130-32-52Recalls & 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 is a cemented hip implant. The FDA records hold 97 reports, with no deaths and 93 injuries; most describe plastic liner wear that can cause bone loss around the implant. There are 2 open recalls: one for liners packaged in non-conforming bags that may wear faster, and one for early wear in certain patients and implant positions. Reports fell to 4 in the last 12 months from 9 in the prior 12 months.
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
- 97
- Deaths reported
- 0
- Injuries reported
- 93
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10885862022165), received between Oct 25, 2019 and Aug 26, 2026 — classified as 93 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (92 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-2117-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Naturally Worn92
- Insufficient Device Problem Information11
- Adverse Event Without Identified Device or Use Problem10
- Loosening of Implant Not Related to Bone-Ingrowth3
- Device Dislodged or Dislocated2
- Unstable2
- Mechanical Problem1
Patient problems
- Failure of Implant57
- Osteolysis46
- Insufficient Information26
- Pain22
- Cyst(s)11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Synovitis7
- Implant Pain5
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Naturally Worn
Patient problems: Pain
MAUDE report 50456479 ↗InjuryJun 9, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, PRESENTED WITH COMPLAINTS OF PAIN AND UNDERWENT A REVISION PROCEDURE. THE REPORT STATED THE COATING CAME OFF OF THE CUP. THE LINER AND CROWN CUP WERE REVISED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Pain
MAUDE report 25451589 ↗InjuryMar 17, 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 24616152 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A TOTAL HIP ARTHROPLASTY, UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIX YEARS THREE MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THE LINER WORE OUT, RESULTING IN TWO HIP DISLOCATIONS, EMERGENCY ROOM VISIT AND FINALLY A HIP REVISION SURGERY. NO FURTHER INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 23907824 ↗InjuryAug 15, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED; REASON UNKNOWN. NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Cyst(s); Insufficient Information; Osteolysis
MAUDE report 22814277 ↗InjuryJun 2, 2025Naturally 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 THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. THE PATIENT PRESENTED FOR A FOLLOW-UP EXAMINATION. X-RAY AND CT SCANS REVEALED DECENTERING OF THE PROSTHETIC HEAD AND OSTEOLYSIS IN THE ACETABULUM, INDICATING PREMATURE INLAY WEAR. AS A RESULT, THE PATIENT WAS REVISED. DURING THE REVISION SURGERY, IN ADDITION TO REPLACING THE INLAY, THE INTEGRITY OF THE ACETABULAR SOCKET WAS CONFIRMED, THE CYSTS IN THE ACETABULAR BED WERE CURETTED AND FILLED WITH HYDROXYLAPATITE + CALCIUM (CERAMENT BONE VOID FILLER), AND THE PROSTHETIC HEAD WAS REPLACED. NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Cyst(s); Insufficient Information; Osteolysis
MAUDE report 22122415 ↗InjuryMay 20, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 7 YEARS POST INITIAL OPERATION. THE PATIENT HAD POLY WEAR/OSTEOLYSIS. PATIENT WAS REVISED TO EXACTECH DEVICES, POLY WAS REPLACED. NO DEVICE BREAKAGE OR SURGERY PROLONGATION REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Osteolysis
MAUDE report 22057513 ↗InjuryFeb 25, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED APPROXIMATELY 6 YEARS PORT INITIAL OPERATION. THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER). AS PART OF THE CHANGE OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.
Patient problems: Cyst(s); Osteolysis
MAUDE report 21459305 ↗InjuryFeb 18, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED APPROXIMATELY 4 YEARS 2 MONTHS POST INITIAL OPERATION. 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 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. 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 (CEREMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.
Patient problems: Cyst(s); Osteolysis
MAUDE report 21404326 ↗InjuryFeb 4, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 131 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AND PAIN. REVISION 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: Failure of Implant; Pain
MAUDE report 21307092 ↗InjuryDec 5, 2024Naturally Worn; Naturally Worn
AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2017. THE DEVICE HAS NOT BEEN EXPLANTED. 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: Insufficient Information
MAUDE report 20852866 ↗InjuryDec 2, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED, THE PATIENT RECEIVED A HIP REPLACEMENT APPROXIMATELY 7 YEARS AND 4 MONTHS PRIOR TO THE REPORT AND THE PLASTIC LINER WAS DEFECTIVE. A REVISION WAS SCHEDULED BUT NOT YET PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20824536 ↗InjuryNov 22, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn
AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT HIP REPLACEMENT. THEY HAD REVISION SURGERY, APPROXIMATELY 57 MONTHS AFTER THEIR INITIAL PROCEDURE. THE PATIENT WAS EXPERIENCING LOSS OF RANGE OF MOTION, IMPLANT PAIN, JOINT LAXITY, AND SWELLING/ EDEMA. 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: Implant Pain; Joint Laxity; Loss of Range of Motion; Swelling/ Edema
MAUDE report 20761692 ↗InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 10 YEARS AND 7 MONTHS POST INITIAL HIP ARTHROPLASTY, THE PATIENT UNDERWENT RIGHT HIP REVISION DUE TO RECALLED HIP LINER. THE EVENT WAS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. RELATED REPORT FOR LEFT HIP REVISION: 1038671-2024-02801.
Patient problems: Insufficient Information
MAUDE report 20569582 ↗InjuryOct 17, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS 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 DECENTRATION OF THE PROSTHESIS HEAD AND SIGNIFICANT OSTEOLYSIS 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 2 36 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 (CEREMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.
Patient problems: Osteolysis
MAUDE report 20471926 ↗InjuryOct 1, 2024Naturally Worn; Naturally Worn
THE PATIENT HAD A HIP PROSTHESIS CUP IMPLANTED. THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF PREMATURE INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.
Patient problems: Insufficient Information; Osteolysis
MAUDE report 20349258 ↗InjurySep 24, 2024Naturally Worn; Naturally Worn
LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 104 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022.
Patient problems: Bursitis; Osteolysis; Pain; Synovitis
MAUDE report 20295814 ↗InjurySep 20, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS MALE PATIENT'S HIP WAS REVISED APPROXIMATELY 6 YEARS 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 MODERATE DECENTRATION OF THE PROSTHESIS HEAD AND CLEAR OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 2, 32MM. 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 20267125 ↗InjurySep 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SEVERE PAIN; SEVERE OSTEOLYSIS, SIGNIFICANT POLYETHYLENE WEAR, CUP HAD MINIMAL FIXATION TO BONE. 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: Joint Laxity; Osteolysis; Pain
MAUDE report 20169404 ↗InjurySep 3, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ADVERSE LOCAL TISSUE REACTION, SYNOVITIS, OSTEOLYSIS, SUPERIOR WEAR OF THE RIM. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Synovitis
MAUDE report 20125475 ↗InjuryAug 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 80 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20031619 ↗InjuryAug 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT WAS REVISED. REASON FOR THE REVISION IS UNKNOWN.
Patient problems: Insufficient Information; Osteolysis
MAUDE report 19999505 ↗InjuryAug 14, 2024Naturally Worn; Naturally Worn
AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT RECEIVED A FAULTY PROSTHESIS THAT IS AFFECTED BY THE RECALL. NO REVISION SURGERY HAS BEEN SCHEDULED. NO OTHER INFORMATION AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 19983336 ↗InjuryAug 12, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS 68 Y/O MALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 10 YEARS 2 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. WORN POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE & EBI ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: CHAIN OF COMMAND.
Patient problems: Pain
MAUDE report 19968906 ↗InjuryAug 12, 2024Naturally Worn; Naturally Worn
LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 113 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19967150 ↗
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-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-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-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-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-2128-2021 · Jun 29, 2021 · Open, ClassifiedExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant
- 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-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-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-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,
- 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, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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