MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 52MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-52
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint effusion (4849)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 5591637 170-50-07 - biolox delta adapter 16/18-12/14; +7mm, 6052608 170-32-50 - biolox delta option femoral head 32mm od.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left hip revision on(b)(6) 2019.Approximately 11 months after the first revision the patient had a second left hip revision on (b)(6) 2020.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 (b)(6) 2020: diagnosis: failed left tha.There was a trochanteric bursitis and a bursectomy was performed.The acetabular component was loose.The allograft bone was more flaky and not bleeding.
Additional Manufacturer Narrative
(h3) the revision reported was likely due to acetabular cup loosening, which may have been the result of an insufficient bond between the acetabular cup and the acetabular bone.However, this cannot be confirmed from the reported information, the revised devices were not available for evaluation, and no images or radiographs were provided.*the following sections have corrected information: d1: brand name.D4: catalog number, expiration date, serial number, unique identifier (udi) #.G4: pma/510(k)number.H4: device manufacture date.
Additional Manufacturer Narrative
The revision reported was likely due to acetabular cup loosening, which may have been the result of an insufficient bond between the acetabular cup and the acetabular bone.However, this cannot be confirmed from the reported information, the revised devices were not available for evaluation, and no images or radiographs were provided.H6: corrected health effect clinical codes.

• Brand Name: NV CROWN CUP CLSTR HOLE 52MM GROUP 2
• 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 ; gainesville, FL 32653
• MDR Report Key: 18093889
• Report Number: 1038671-2023-02720
• Device Sequence Number: 17598177
• Product Code: JDI
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2020
• 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): 01/09/2025

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: 05/17/2017
• Device Catalogue Number: 180-01-52
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 08/01/2024; 01/09/2025
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 08/27/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female