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 Codes	Osteolysis (2377); Insufficient Information (4580)
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 bilateral hip replacement procedure on (b)(6) 2020 and then had a bilateral revision surgery 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 implants, it was found that the acetabular liners had grossly mild wear.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.
Additional Manufacturer Narrative
Pending investigation.D10: n/a 32135-38h - 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 7.(b)(6); 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6); 180-65-25 - alteon 6.5mm screw, 25mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: d6a/d6b, h6.Mdr section codes updated/corrected: b, c, d, e, g.The most likely cause for the reported revision due to prosthesis wear and osteolysis 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.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 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19913604
• Report Number: 1038671-2024-02687
• Device Sequence Number: 20859138
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 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: 02/11/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 02/12/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female