MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 56MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	180-01-56
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tha on (b)(6) 2013.The patient was revised on (b)(6) 2023.Acetabular components were loose.All components were removed and competitor acetabular components were implanted.Replaced original exactech hip head with revision sleeve and head.The patient was stable at the conclusion of the case.There was no reported breakage of a device or surgical delay/prolongation.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.D10: 120-65-25 - bone screw 6.5mm dia x 25mm long 2575509.120-65-35 - bone screw 6.5mm dia x 35mm long 2056060.136-36-53 - nv gxl lnr, +5lat, 36mm g3-56/58mm cups 2461811.160-31-14 - pf spline plasma w/ha ext offset sz 14 2181254.142-36-00 - cocr fem head 36mm +0 offset 12/14 2629381.H7: z-2128-2021.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of acetabular cup loosening that occurred over approximately 9 years and 10 months of use.The patient involved in this case meets the following risk criteria for early wear as specified in the hhe: implanted with a lateralized liner.However, no wear was reported in this case.The acetabular cup loosening 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 and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of acetabular cup loosening that occurred over approximately 9 years and 10 months of use.The patient involved in this case meets the following risk criteria for early wear as specified in the hhe: implanted with a lateralized liner.However, no wear was reported in this case.The acetabular cup loosening 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 and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17322369
• Report Number: 1038671-2023-01660
• Device Sequence Number: 20217946
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 02/06/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2017
• Device Model Number: 180-01-56
• Device Catalogue Number: 180-01-56
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 04/24/2024; 02/05/2025
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 04/26/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male