MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, this patient had right hip replacement on (b)(6) 2016.They had revision surgery (b)(6)2020, approximately 4 years 9 months after their initial procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
Revision operative report of (b)(6) 2020: postoperative diagnosis- failed right total hip replacement due to instability with dislocation- acetabular revision.Revised to non exactech all poly constrained cup.Stem stable and well fixed.Polyethylene liner from the non exactech cup.Implanted: non exactech all poly constrained cup /22mm +0 cobalt chrome head for exactech stem.
Additional Manufacturer Narrative
H10.Additional/updated information ¿ a2, a3, b5, d1, d4 all, d10, g4 510k, h4 h6 health effect - clinical code & medical device problem code.D10.Concomitants: 170-32-03 - biolox delta femoral head 32mm od, +3.5mm (b)(6).180-65-20 - alteon 6.5mm screw, 20mm (b)(6),180-65-25 - alteon 6.5mm screw, 25mm (b)(6), 188-01-02 - wedge plasma x/o sz 2 (b)(6).130-32-52 - nv gxl linr, ntrl, 32mm id, group 2 cups (b)(6).H6.Investigation results- nv crown cup clstr hole 52mm group 2, with sn (b)(6) was revised, with out mention of damage or issue in the operative report.The cause of the patient¿s pain and instability and the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-04484 the following sections were updated: g1.The following sections were corrected: g1, h6 the most likely underlying cause for the revision reported is a combination of risk factors specified such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17034551
• Report Number: 1038671-2023-01187
• Device Sequence Number: 12365416
• Product Code: LZO
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2024

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
• Device Expiration Date: 11/14/2020
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 180-01-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 12/07/2023; Not provided
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 12/07/2023; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female