MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-32-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total hip replacement procedure on (b)(6) 2020 and then was revised approximately 3 years 8 months later on (b)(6) 2023.Patient was recommended elective revision surgery due to implant recall for prosthesis wear.During the removal of the original implant, gross findings of the right hip joint included moderate wearing of the articular bearing.There was mild lysis of the bone around the rim of the acetabulum around the proximal aspect of the femur after dissection of associated soft tissue with a rongeur and a curette.The patient was transferred to recovery in stable condition; no complications and procedure was tolerated well.The patient was revised to exactech devices.There is no other information provided/available.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6) - flex drill m3.2x38 hd lenkbar.(b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.(b)(6) 188-00-08 - wedge plasma s/o sz 8.(b)(6) 170-32-00 - biolox delta femoral head 32mm od, +0mm.(b)(6) 188-01-07 - wedge plasma x/o sz.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.H7: recall number (z-1729-2022).H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Additional Manufacturer Narrative
This event was determined to be a duplicate of case(b)(4)/ 1038671-2024-00928.Please reference 1038671-2024-00928 for additional information.

• Brand Name: NV GXL LNR, LIPPED 32MM ID GROUP 2 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19154867
• Report Number: 1038671-2024-00930
• Device Sequence Number: 7407012
• Product Code: JDI
• UDI-Device Identifier: 10885862023315
• UDI-Public: 10885862023315
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: 09/29/2024
• Device Catalogue Number: 132-32-52
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female