MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 54MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV CROWN CUP CLSTR HOLE 54MM GROUP 2
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products bone screw 6.5mm dia x 35mm long (cat# 120-65-35 / serial# (b)(4)).Nv gxl lnr, +5lat, 36mm g2-52/54mm cups (cat# 136-36-52 / 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 7 yrs postop the initial ltha, the (b)(6) male patient was complaining of discomfort and cup loosening was noted on x-ray.All acetabular components were explanted and replaced with a competitor.Femoral stem remained intact and femoral head was replaced with a femoral head 28mm od and adapter +3.5mm.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.
Additional Manufacturer Narrative
H3: the evaluation noted that revision reported was likely the result of an insufficient bond between the acetabular cup and the bone, which led to aseptic (non-infected) acetabular cup loosening.However, this cannot be confirmed as the devices were not returned for evaluation and x-ray images were not provided.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.

• Brand Name: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12128424
• Report Number: 1038671-2021-00325
• Device Sequence Number: 4424777
• Product Code: JDI
• UDI-Device Identifier: 10885862037022
• UDI-Public: 10885862037022
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 10/31/2018
• Device Model Number: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• Device Catalogue Number: 180-01-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 71 YR