MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	140-36-52
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 52mm crown cup cluster hole 180-01-52 alteon ha std sz4 190-30-04 cocr head 36mm +3.5 142-36-03.
Event or Problem Description
It was reported that this 72 y/o female patient's right hip was revised.The surgeon revised the liner to a new xle liner and the head from a cocr to a biolox options head.Reason for the revision is unknown, possibly due to the recall.The patient was stable with original implants.Doctor removed the head and then he liner.He checked the stability of the cup and the stem both were well fixed.He then implanted a new g2 xle liner and a biolox options 36 +3.5 head.The patient originally had a 35 +3.5 cocr head in with a g2 xle neutral liner.The patient was reduced and was stable at time of implantation.Patient was last known to be in stable condition following the event.No x-rays or images obtained.Product not returning, doctor kept implants.
Additional Manufacturer Narrative
(h3) this case was determined to be a duplicate of (b)(4)/038671-2023-02717.All further information pertaining to this case will be captured under 1038671-2023-02717.

• Brand Name: NV EHXL NTRL LNR G2 36MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17641672
• Report Number: 1038671-2023-02077
• Device Sequence Number: 5680223
• Product Code: JDI
• UDI-Device Identifier: 10885862537317
• UDI-Public: 10885862537317
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/17/2024

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 Catalogue Number: 140-36-52
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Patient Age: 72 YR
• Patient Sex: Female