MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 48MM GROUP 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV CROWN CUP CLSTR HOLE 48MM GROUP 1
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, approximately five years post initial tha, this female patient experience severe pain in her right hip, and was subsequently diagnosed with loosening of the hip system and polyethylene wear of the acetabular component.Patient had sustained severe and permanent injuries; she was required to undergo multiple permanent and painful revision surgeries, including the removal and re-implantation of a replacement prosthetic hip.She has required many months of hospitalization, physical therapy, and other care.She has and will continue to be bedridden.She has and will continue to experience sever and permanent pain; and she has and will continue to suffer severe and permanent complications and other injuries to the right hip.
Additional Manufacturer Narrative
After further review of additional information received.Section d10: concomitant medical products: nv gxl liner neutral, 32mm id group 1 cups (cat# 130-32-51 / serial#: (b)(6) cocr fem head 32mm +0 offset 12/14 (cat# 142-32-00 / serial#: (b)(6).Alteon 6.5mm screw, 25mm (cat#: 180-65-25 / serial#: (b)(6).Alteon 6.5mm screw, 25mm (cat#: 180-65-25 / serial#: (b)(6).Wedge plasma s/o sz 5 (cat#: 188-00-05 / serial#: (b)(6).(h3) the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear after being implanted for 5+ years.However, this cannot be confirmed as the devices were not available for evaluation and no pictures or x-rays were provided at the time of this evaluation.It should also be noted that using a group 1 acetabular liner with a 32mm femoral head creates a combination of the largest available head and the thinnest available acetabular liner (for group 1), which is a risk factor for early wear and lysis.The most probable root cause associated with the reported event of "loosening¿ is associated with weakened integration of the device 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 "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
Additional information received 31-mar-2023: investigation has been reopened.
Event or Problem Description
As reported via legal documentation, female patient had initial right total hip replacement (b)(6) 2015 due to right hip degenerative arthritis.Revision operative report of (b)(6) 2021, approximately 6 years 6 months after their initial replacement, for right hip-preoperative diagnosis: aseptic loosening right total hip replacement "a complete synovectomy is performed.The liner had near complete wear on the superiorlateral aspect.The two screws are removed.The cup is grossly loose and removed.There is large contained osteolytic defect in the socket.The pseudomembrane in the socket is debrided. sterile dressings are applied.The patient tolerated the procedure well, without complication and transferred to the recovery room in a stable postoperative condition.
Additional Manufacturer Narrative
The information provided in the revision operative report does not require a new investigation.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: NV CROWN CUP CLSTR HOLE 48MM GROUP 1
• 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: 13500418
• Report Number: 1038671-2022-00191
• Device Sequence Number: 5328020
• Product Code: JDI
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2023

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: 06/16/2020
• Device Model Number: NV CROWN CUP CLSTR HOLE 48MM GROUP 1
• Device Catalogue Number: 180-01-48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 03/31/2023; 07/13/2023
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 08/22/2022; 04/26/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female