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

Catalog Number	130-28-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: "(b)(6), 186-01-48 - integrip cc, cluster 48mm, g1; (b)(6), 186-01-50 - integrip cc, cluster 50mm, g1; (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6), 190-30-03 - alt ha s clr std sz 3; (b)(6), 190-30-03 - alt ha s clr std sz 3; (b)(6), 170-28-00 - biolox delta femoral head 28mm od, +0mm; (b)(6), 170-28-00 - biolox delta femoral head 28mm od, +0mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (mdl no.(b)(4)): (b)(4) is associated with this case.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.(b)(4), and pending in the eastern district of (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.Unable to confirm specific devices due to bilateral ebi invoice data.The serial number (b)(6) are confirmed to be a part of recall number: z-1729-2022.130-28-51 - nv gxl linr, ntrl, 28mm id, group 1 cups; serial: (b)(6); 510k: k070479; udi: (b)(4); product code: jdi, lph, lwj, lzo, meh; x-ray: no; operative notes: no.Concomitant devices: (b)(6), 186-01-48 - integrip cc, cluster 48mm, g1; (b)(6), 186-01-50 - integrip cc, cluster 50mm, g1; (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6), 190-30-03 - alt ha s clr std sz 3; (b)(6), 190-30-03 - alt ha s clr std sz 3; (b)(6), 170-28-00 - biolox delta femoral head 28mm od, +0mm; (b)(6), 170-28-00 - biolox delta femoral head 28mm od, +0mm.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20431197
• Report Number: 1038671-2024-03954
• Device Sequence Number: 7860321
• Product Code: JDI
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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 Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/11/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown