MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: bone screw 6.5mm dia x 25mm long (cat# 120-65-25 / serial# (b)(4)).Pf stem tapered plasma sz 16 (cat# 160-00-16 / serial# (b)(4)).Biolox delta femoral head 36mm od, +0mm (cat# 170-36-00 / serial# (b)(4)).Nv crown cup clstr hole 60mm group 4 (cat# 180-01-60 / serial# (b)(4)).Platelet rich plasma kit with spray tips (cat# 620-00-02 / serial# (b)(4)).Accelerate conc.Sys rep by 620-12-02 (cat# 620-11-02 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eleven years post initial right side tha, this male patient was revised as he was having hip pain and mri showed fluid collection in the pelvis from the liner wear.Head liner exchange to a novation xle 36mm liner was performed.Hip was stable with range of motion (rom) testing.Patient was last known to be in stable condition.X-rays and photos attached.Devices are not available for evaluation due to hospital does not release the implant to the rep.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of edge loading and being implanted for over 10 years, which led to polyethylene wear and pain.However, this cannot be confirmed as the device was not available 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
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of edge loading and being implanted for over 10 years, which led to polyethylene wear and pain.However, this cannot be confirmed as the device was not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, LIPPED, 36MM ID GROUP 4 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: 13732516
• Report Number: 1038671-2022-00238
• Device Sequence Number: 4710482
• Product Code: JDI
• UDI-Device Identifier: 10885862023438
• UDI-Public: 10885862023438
• 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: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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: 01/12/2013
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS
• Device Catalogue Number: 132-36-54
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 02/26/2025
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 08/17/2022; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male