MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the radiological findings of the patients treated with this implant were checked.An increased decentering of the head in the inlay for 5 years after implantation and pronounced osteolysis in the bony interface of the metal socket were evident as signs of significant inlay wear.
Additional Manufacturer Narrative
(h3) in march, 2021, exactech received user mir reports from bfarm related to 4 cases reported by surgeons at westersede hospital in germany for wear of the gxl polyethylene acetabula liner.Further investigation with the surgeons at (b)(6) revealed that they had 18 patients (11 unilateral and 7 bilateral), with 22 gxl liners that were exhibiting signs of wear potentially requiring revision.The following complaints were entered into the global complaint handling system to document the analyses of these cases and vigilance reporting report.The mechanisms of wear of polyethylene acetabular liners are clinically well known in total hip arthroplasty (tha).¿conventional¿ uhmwpe has good mechanical properties but is inherently prone to wear.¿highly¿ cross linking has helped with wear but increased risk of liner fractures when used with modern locking mechanisms, large heads, thinner liners.Cup malposition can further lead to edge loading/early fracture; thus, some companies chose to use ¿moderate¿ x linking of the polyethylene liner to optimize fracture resistance and improve wear properties.Exactech took this approach with the gxl moderately crosslinked acetabular liner.In a worldwide analysis of gxl failures, common characteristics revealed that components positioned with anteversion and/or abduction (often seen with anterior approaches) result in edge loading of the gxl liner.This is combination with large femoral heads with thinnest liner, and/or lateralized or face changing liners further increases the risk for wear of the gxl liner ( ~2.Ox greater and ~2.5x greater, respectively).Westerstede hospital provided 18 sets of x-rays (11 unilateral hip/7 bilat) and clinical notes (de-identified) for all reported patients.Dr.Sharat kusuma received and analyzed all data in collaboration with the westerstede surgeons.The findings were as follows: average cup abduction on ap xray: 51° (range 45 65), 16/25 (64%) had evidence of edge loading, 16/25 (64%) were thin inlays/large femoral heads, 96% of cups were well fixed.In conclusion, it was determined that most of these are best treated with liner exchange; however, 2-3 patients may potentially require revision of entire construct (inlay + shell) due to loosening of the acetabular shell.The surgeons at westerstede hospital have determine that optimal treatment course for these patients is exchange of gxl to exactech¿s highly crosslinked xle liner.As the xle liner is not approved for use in germany, they are actively seeking special access approval/humanitarian use exemption from the germany authority, bfarm.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 11731355
• Report Number: 1038671-2021-00197
• Device Sequence Number: 16942166
• Product Code: JDI
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 08/11/2019
• Device Model Number: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Device Catalogue Number: 136-32-52
• 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: 04/08/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female