MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products.Cocr fem head 32mm +3.5 offset 12/14 (cat#: 142-32-03 / serial#: (b)(4)).32 neutral gxl liner.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5 yrs postop the initial implant, this (b)(6) y/o female patient was revised due to the gxl poly wore out and the femoral head started to wear out the intergrip shell.The cup and liner were removed.The head was replaced.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy doesn't allow explants to be removed from the hospital.
Additional Manufacturer Narrative
(h3) the most likely underlying cause for the revision reported cannot be determined at this time due to inconsistent information received.From the information provided by the sales representative, it is possible that the acetabular liner wore and/or partially detached from the acetabular cup, allowing for the femoral head to articulate directly with the cup.This may have led to the pseudotumor, metallosis, and necrotic tissue reported through the patient¿s legal representative.However, this cannot be confirmed and the cause of any liner wear and/or detachment cannot be determined because the components were not returned for evaluation.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of wear of the acetabular liner which may have been due to edge loading/impingement, orientation of the acetabular cup, and/or patient related conditions.The reported wear of the cup was likely due to the implant directly articulating with the femoral head as a result of the liner becoming worn.However, this cannot be confirmed because the components were not returned for evaluation.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Event or Problem Description
As reported via legal documentation on or about (b)(6) 2015, the patient underwent hip replacement surgery, then approximately 6 years 1 month later on (b)(6) 2021 the patient was experienced a surgical revision.It is stated in the legal document that the components corroded causing a pseudotumor, metallosis, and necrotic tissue within the implant area.No other information.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 other information is available.
Additional Manufacturer Narrative
H10.Additional/updated information: b5, b6, b7, d2a/d2b, d8, d10 d10.Concomitants: 120-65-20 - bone screw 6.5mm dia x 20mm long, sn (b)(6).164-13-10 - novation element ro s/o col sz 10, sn (b)(6).142-32-03 - cocr fem head 32mm +3.5 offset 12/14, sn (b)(6).186-01-48 - integrip cc, cluster 48mm, g1, sn (b)(6).No other information is available.H11.Correction -d6a, g4 510k.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11438913
• Report Number: 1038671-2021-00097
• Device Sequence Number: 19773750
• Product Code: LZO
• UDI-Device Identifier: 10885862038753
• UDI-Public: 10885862038753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 10/25/2021
• Device Model Number: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 06/29/2021; 11/13/2023
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/16/2021; 07/21/2021; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG