MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Osteolysis (2377)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitant medical products: serial #: (b)(4) ,category #: 150-23-00 - modular xtra small meta 23mm, serial #: (b)(4) , category #: 150-07-16 - modular straight stem 13mm x 165mm, serial #: (b)(4) , category #: 158-02-06 - 12/14 lpb m-series neck low offset +0, serial #: (b)(4) ,category #: 142-28-03 - cocr fem head 28mm +3.5 offset 12/14, serial #: (b)(4) ,category #: 120-65-20 - bone screw 6.5mm dia x 20mm long, serial #: (b)(4) , category #: 120-65-35 - bone screw 6.5mm dia x 35mm long, serial #: (b)(4) ,category #: 101-05-01 - drill bit 1 pk 3.2mm dia x 32mm lng, serial #: (b)(4) ,category #: 101-05-03 - drill bit 1 pk 4.5mm dia x 32mm lng, serial #: (b)(4) ,category #: 180-01-48 - nv crown cup clstr hole 48mm group 1, serial #: (b)(4) ,category #: 120-65-15 - bone screw 6.5mm dia x 15mm long.
Event or Problem Description
Legal case (b)(6).As reported via legal documentation, this patient is an 80 year old female with a verified right hip on (b)(6) 2013.She had a right hip revision on (b)(6) 2022, approximately 8 years and 4 months after their initial surgery.Postop diagnosis: right hip osteolysis after previous total hip arthroplasty.Revised to exactech novation xle.The patient was taken to the recovery room in stable condition.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.Serial #: (b)(4), category #: 130-28-51 - nv gxl linr, ntrl, 28mm id, group 1 cups, serial number (b)(4) , is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k070479.Concomitants: serial #: (b)(4) , category #: 150-23-00 - modular xtra small meta 23mm, serial #: (b)(4), category #: 150-07-16 - modular straight stem 13mm x 165mm, serial #: (b)(4) , category #: 158-02-06 - 12/14 lpb m-series neck low offset +0, serial #: (b)(4) , category #: 142-28-03 - cocr fem head 28mm +3.5 offset 12/14, serial #: (b)(4) , category #: 120-65-20 - bone screw 6.5mm dia x 20mm long, serial #: (b)(4), category #: 120-65-35 - bone screw 6.5mm dia x 35mm long, serial #: (b)(4), category #: 101-05-01 - drill bit 1 pk 3.2mm dia x 32mm lng, serial #: (b)(4) , category #: 101-05-03 - drill bit 1 pk 4.5mm dia x 32mm lng, serial #: (b)(4), category #: 180-01-48 - nv crown cup clstr hole 48mm group 1, serial #: (b)(4), category #: 120-65-15 - bone screw 6.5mm dia x 15mm long.
Additional Manufacturer Narrative
H3: based on the available information, the revision involved in the case may have been the result of a combination of the risk factors specified in the hhe including but not limited to use error, implant positioning, and patient factors, which led to osteolysis.However, this cannot be confirmed as the devices, radiographs, and photographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, e4: removed erroneous entry, f10: removed erroneous entries, g1, g2, h6: clinical code, medical device problem code, component code, and type of investigation.Based on the available information, the revision involved may have been the result of a combination of the risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) including but not limited to use error, implant positioning, and patient factors, which led to osteolysis.However, this cannot be confirmed as the devices, radiographs, and photographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation, this patient is a female with a verified right hip.She had a right hip revision, approximately 8 years and 4 months after their initial surgery.Postop diagnosis: right hip osteolysis after previous total hip arthroplasty.Revised to exactech novation xle.The patient was taken to the recovery room in stable condition.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.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523782617
• MDR Report Key: 16717352
• Report Number: 1038671-2023-00644
• Device Sequence Number: 7274504
• Product Code: LZO
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2017
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 02/17/2026
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 09/12/2023; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female