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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: exactech stent, mini vision otw 2x18 ref# 601520, s/n (b)(6), exactech novation gxl lipped 32mm acetabular liner 1323252 ref# 752325, s/n (b)(6), exactech screw bone acet 6.5x25mm, s/n (b)(6), exactech femoral head 32 mm o.D., ref# 1703203, s/n (b)(6), and exactech femoral stem, ref# 1880008, s/n (b)(6).Novation crown cup connexion gxl neutral liner 1323252, pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6) 2019.Approximately 3 years and 1 month after the initial procedure the patient had a right hip revision on (b)(6) 2022.There is no information on the surgical procedure or patient outcome.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H11.Additional manufacturer narrative- this event and the devices have been discovered to be a duplicate case and initially reported under mfr# 1038671-2022-01189.All new and/or additional information will be reported in mfr# 1038671-2022-01189.

• 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
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18317544
• Report Number: 1038671-2023-02968
• Device Sequence Number: 15019715
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 10/28/2019
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown