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 Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6) 2015.Approximately 8 years and 7 months after the initial procedure the patient had a right hip revision on (b)(6) 2023.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.Revision op report on (b)(6) 2023, diagnosis: central subluxation of right hip findings: evidence of previous subluxation events with wear and fracturing of posterior polyethylene liner.No evidence of purulence or signs of infection.The patient was transferred to the bed and then recovery room in stable condition.
Additional Manufacturer Narrative
The most 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 may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Additional manufacturer narrative- additional codes added.H3.Additional information- all complaint occurrence rates were calculated to be <0.5%.This is considered ¿very low¿.Therefore, this issue does not appear to be design related.Exactech is not aware of any other complaints involving parts from this constrained liner¿s manufacturing lot of (b)(4) units.The device history record (dhr) for this constrained liner was reviewed, and all components were accepted with conformance to the device requirements.There is no other information available.Listed in the product labeling: ¿excessive wear¿, ¿dislocation¿, and ¿prosthesis fracture¿.The potential risks are captured in the risk documents.There is no additional information available.

• 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
• MDR Report Key: 18190462
• Report Number: 1038671-2023-02839
• Device Sequence Number: 7321609
• Product Code: JDI
• UDI-Device Identifier: 10885862023315
• UDI-Public: 10885862023315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 09/04/2019
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 05/24/2024; 06/18/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 06/04/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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 Age: 84 YR
• Patient Sex: Female