MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 32inm polyethylene acetabular liner (cat# 136-32-51/lot# 1561995); 32mm -3.5 femoral head (cat# 148-32-93); size 9 femoral stem (cat# 164-03-09/lot# 2047256).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, plaintiff underwent revision surgery to remove the defective device, excise a large osteolytic cyst, and rebuild bone support a new acetabular cup.The device implanted into plaintiff was defective and unreasonably dangerous in that the acetabular liner catastrophically fractured, which allowed the femoral head to articulate directly against the initial cup and cause severe pain and injury to the plaintiff and necessitated a revision surgery only eight years after implant.Plaintiffs learned for the first time that the device was defective after its removal on or about (b)(6) 2020.As a direct result of the defective nature of the device, the plaintiff has suffered and continues to suffer permanent and debilitating injures and drainages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening, impingement and/or detachment; metallosis; soft tissue damage; adverse local tissue reaction; and other injuries presently undiagnosed, which all require ongoing medical care.As a further direct result, the plaintiff has sustained and will sustain future damages, including but not limited to additional revision surgeries; cost of medical care; rehabilitation; hone health care; lost wages; loss of earning capacity; mental and emotional distress; and pain and suffering.
Additional Manufacturer Narrative
(h3) the most likely underlying cause of the prosthesis fracture and the type of fracture reported cannot be determined from the information provided.It is unclear if the acetabular liner locking button failed, allowing for the liner to move from its intended location within the acetabular cup, if the liner wore through, or if there was a fracture around the liner rim, which led to the femoral head articulating directly against the acetabular cup.The most probable root cause associated with the reported event of "prosthesis fracture" is an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.Section d1:brand name section d10: concomitant medical products.Nv crown cup clstr hole 48mm group 1 (cat# 180-01-48 / serial# (b)(6).
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of edge loading and extensive edge wear of the acetabular liner, which led to material loss and articulation between the femoral head and the acetabular cup.The most likely cause for the prosthesis wear observed is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.The locking button was also found to have fractured.However, the lack of damage to the backside of the liner suggests that the full-thickness fracture occurred immediately before or during the revision surgery and does not appear to have contributed to the femoral head ¿ acetabular cup contact or the extensive wear of the acetabular liner.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.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM 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: 12787773
• Report Number: 1038671-2021-00608
• Device Sequence Number: 3840346
• Product Code: JDI
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2023

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: 10/06/2013
• Device Model Number: NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 01/25/2023
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/29/2021; 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male