MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	136-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.D10.Concomitants - product information: 2406748-180-01-56 - nv crown cup clstr hole 56mm group 3; 2428120-120-65-20 - bone screw 6.5mm dia x 20mm long; 2484165-101-05-20 - 3.2mm drill bit 20mm 1pk ; 2544461-164-03-09 - element-stem, collared w/ha, std offset, sz 9; 2774532-170-36-00 - biolox delta femoral head 36mm od, +0mm; 2794435-120-65-20 - bone screw 6.5mm dia x 20mm long.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that the patient was implanted with a novation gxl device on the left hip and then approximately 9 years, 4 months later the patient was revised.It is stated the patient has suffered the following injuries and complications: pain, difficulty with everyday activities, trouble walking and required revision surgery.There was no other patient/medical information provided.No x-rays or images were provided.There is no device return.There is no other information available.
Additional Manufacturer Narrative
H6: corrected the following: component code, and investigation codes.Manufacturer narrative: based on the available information, the patient involved meets the following criteria for early prosthesis wear and/or osteolysis; implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear is 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).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19575410
• Report Number: 1038671-2024-02041
• Device Sequence Number: 4056840
• Product Code: LZO
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2013
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2009
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown