Novation 130-36-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10885862022233), received between Feb 11, 2020 and Jul 10, 2026 — classified as 78 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (71 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 16, 2026.

Recalls naming this device

1. Aug 11, 2022Open, 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 ↗

2. Jun 29, 2021Open, 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-2118-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE LINER BECAME DEFECTIVE. AS A RESULT, THE PATIENT UNDERWENT A HIP REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25779166 ↗
• InjuryMar 30, 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 24727910 ↗
• InjuryMar 23, 2026Naturally Worn

  IT WAS REPORTED A PATIENT, WHO HAD A 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: Insufficient Information

  MAUDE report 24671352 ↗
• InjuryJul 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS POST OP. SURGEON REMOVED OF STEM AND FEMORAL COMPONENT. THE PATIENT ALLEGED FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL OF THE PROSTHESIS AT ISSUE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain

  MAUDE report 22560907 ↗
• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 3 MONTHS POST OP DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain

  MAUDE report 22123807 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 69 YO MALE PATIENT, INITIAL LEFT HIP IMPLANTED IN (B)(6)2015, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 9 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR LEFT HIP. UPON EXAMINATION, THE PATIENT HAS ACETABULAR POLYETHYLENE WEAR AND HAS A RECALLED POLY IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT UNDERWENT AN ACETABULAR POLYETHYLENE SWAP AND A FEMORAL HEAD SWAP. THE PATIENT LEFT THE OR STABLE. THERE WAS NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE FACILITY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21645357 ↗
• InjuryJan 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 53 YO MALE PATIENT, INITIAL LEFT HIP IMPLANTED IN (B)(6) 2014, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 10 YEARS 1 MONTH POST THE INITIAL IMPLANT. THE PATIENT PRESENTED BACK TO THE SURGEON¿S OFF WITH COMPLAINTS OF THEIR THA, INCLUDING PAIN, STIFFNESS, AND DISSATISFACTION. THE PATIENT HAS A RECALLED HIP POLYETHYLENE LINER, WHICH WAS WORN OUT ON THE X-RAY. THE PATIENT WAS SCHEDULED FOR A THA REVISION ON (B)(6)2024, DURING WHICH THE PATIENT UNDERWENT A POLY ACETABULAR LINER SWAP AND FEMORAL HEAD SWAP. THE LINER WAS CHANGED FROM A NEUTRAL STYLE TO A +5 LATERALIZED COMPONENT AND THE FEMORAL HEAD LENGTH WAS INCREASED. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 15-30 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO IMPACT TO THE PATIENT. THEY ADDRESSED AN EXTENSIVE BONE/OSTEOPHYTE AND SCAR TISSUE GROWTH AROUND THE ACETABULAR CUP THAT TOOK EXTRA TIME TO RESECT AND CLEAR. ALSO THE FIRST REPLACEMENT ACETABULAR LINER WOULD NOT LOCK IN PROPERLY AND WAS WASTED. THE ACETABULAR RIM WAS CLEARED AGAIN AND A SECOND POLY LINER WAS OPENED AND IMPLANTED. THE SECOND IMPLANT DID LOCK IN PROPERLY. X-RAYS WERE PROVIDED. THE PATIENT LEFT THE

  Patient problems: Discomfort; Pain; Scar Tissue

  MAUDE report 21150883 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND RESTRICTION OF MOTION, UNABLE TO ATTEND TO TASKS OF DAILY LIVING, LOSS OF CONSORTIUM, FURTHER SURGERY NEEDED TO REMOVE THE DEVICE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 20880443 ↗
• InjuryNov 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 63 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2015, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 9 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, AND DISSATISFACTION WITH THEIR HIP. UPON EXAMINATION, THE PATIENT HAS A RECALLED POLY LINER. THE PATIENT WAS SCHEDULED FOR A REVISION TOTAL HIP REPLACEMENT POSSIBLE POLY LINER AND FEMORAL HEAD SWAP. THE PATIENT HAD REVISION SURGERY AND UNDERWENT A POLY ACETABULAR LINER SWAP AND A FEMORAL HEAD SWAP. THEY WERE REVISED TO NV EHXL NTRL LNR G3 40MM (B)(6) BIOLOX DELTA ADAPTER 16/18-12/14; +3.5MM B110877 BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD (B)(6). 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 AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THEY WERE SENT TO THE LAB AND LEGAL HOLD AT THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 20616578 ↗
• InjuryOct 30, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 133 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR; SIGNIFICANT PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, DIFFICULTY WALKING, ANTALGIC GAIT, TISSUE DESTRUCTION, BONE DESTRUCTION, LOSS OF MOBILITY; ONGOING MEDICAL CARE, ADDITIONAL SURGERIES; ANXIETY AND EMOTIONAL DISTRESS. 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Inflammation; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20570234 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  EMAIL TO COMPLAINTS USA. HIP REVISION. PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS PATIENT'S HIP WILL BE REVISED. AT THIS TIME PLAN IS FOR HEAD AND LINER EXCHANGE WITH POLY WEAR. ACETABULAR CYST PRESENT, NO FURTHER INFORMATION AT THIS TIME. HI DR. (B)(6), I HOPE YOU ARE WELL. I AM REACHING OUT REGARDING AN UPCOMING HIP REVISION WITH EXACTECH IMPLANTS SCHEDULED ON OCT 22. I AM YOUR REP FOR THE CASE. CAN YOU PLEASE PROVIDE ME PATIENT NAME AND DOB SO I CAN ACQUIRE IMPLANT... GOOD MORNING, PATIENT IN QUESTION IS (B)(6), (B)(6)1963. AT THIS TIME PLAN IS FOR HEAD AND LINER EXCHANGE WITH POLY WEAR. ACETABULAR CYST PRESENT SO CHANCE WE HAVE TO REVISE ACETABULAR COMPONENT AND WILL PLAN ON REMOVING ACETABULAR SCREWS AT THE VERY LEAST. APPRECIATE YOUR ASSISTANCE WITH THIS CASE. SINCERELY, (B)(6). 130-36-53 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS 1814297. UDI NUMBER (B)(4). 510(K) NUMBER K070479. PRODUCT CODE JDI, LPH, LWJ, LZO, MEH. RECALL NUMBER Z-1729-2022. CONCOMITANTS: 150-07-17 - MODULAR STRAIGHT STEM 13MM X 200MM 1486245, 150-25-01 - MODULAR SMALL META 25MM 1556745, 122-65-40 - 6.5MM ACETABULAR BONE SCREW 40MM 1654171, 122-65-25 - 6.5MM ACETABULAR BONE SCREW 25MM 1654281, 158-02-01 -

  Patient problems: Cyst(s); Insufficient Information

  MAUDE report 20553359 ↗
• InjurySep 16, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AFTER A HIP REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20231875 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 118 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS, NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, PAIN FOLLOWING REVISION SURGERY AND RECUPERATION/REHABILITATION AND PHYSICAL THERAPY; LIMITED ABILITY TO PERFORM NORMAL ACTIVITIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Muscle Weakness/Atrophy; Pain

  MAUDE report 20200799 ↗
• InjurySep 11, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192107 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A LEFT 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.".

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

  MAUDE report 20192074 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20126242 ↗
• InjuryAug 12, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 95 MONTHS AFTER A TOTAL LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXTENSIVE OSTEOLYSIS, SYNOVITIS, SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. 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; Pain; Synovitis

  MAUDE report 19960383 ↗
• InjuryAug 9, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA: IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Failure of Implant

  MAUDE report 19953760 ↗
• InjuryAug 7, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE IN 2017 AND WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR AND PAIN. 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: Osteolysis

  MAUDE report 19929701 ↗
• InjuryJul 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PREMATURE, UNNECESSARY REVISION SURGERY; TISSUE AND BONE LOSS. 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; Pain

  MAUDE report 19731604 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 80 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE, OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19655879 ↗
• InjuryJun 12, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 133 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: Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19518594 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A REVISED RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A 2ND REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19341454 ↗
• InjuryMay 17, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 3 MONTHS AFTER A RIGHT 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: Failure of Implant; Insufficient Information

  MAUDE report 19341345 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THE APPROXIMATELY 105 MONTHS AFTER A TOTAL RIGHT HIP REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE REVISION PROCEDURE DUE TO POLYETHYLENE WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Scar Tissue

  MAUDE report 19323878 ↗

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-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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, Classified
  Exactech 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, 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,
• 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-2128-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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, Classified
  Exactech 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-2132-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-2127-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-2126-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech 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-0787-2013 · Nov 5, 2012 · Terminated
  Exactech 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 · Terminated
  Exactech 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