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

Model Number	NV CROWN CUP CLSTR HOLE 56MM GROUP 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: bone screw 6.5mm dia x 25mm long (cat# 120-65-25 / serial# (b)(4) ).Nv gxl lnr, lipped, 36mm id, group 3 cups (cat# 132-36-53 / serial# (b)(4) ).Cocr fem head 36mm +0 offset 12/14 (cat# 142-36-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 10.5 years post initial right tha, the (b)(6) year old male patient was brought back for osteolysis of the right hip.The hip was dislocated, femoral head removed, stem found to be well fixed.Attention turned to cup.The liner was removed with the use of a chisel, the bone screw was removed.The cup found to be loose and was removed.The patient received 40cc of optecure mixed with a crushed femoral head allograft.A biomet g7 multihole cup with dual mobility was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The devices will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of deterioration of the bond between the acetabular cup and the bone after being implanted for over 10 years, patient-related conditions, or a combination of these possibilities, which led to aseptic (non-infected) acetabular cup loosening and osteolysis.The most probable root cause associated with the reported event of "loosening - acetabular¿ is associated with weakened integration of the acetabular component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with the reported event of "osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14526872
• Report Number: 1038671-2022-00624
• Device Sequence Number: 20338081
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• 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: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 06/20/2016
• Device Model Number: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• Device Catalogue Number: 180-01-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male