MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 58MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV CROWN CUP CLSTR HOLE 58MM 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	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: nv gxl linr, ntrl, 36mm id, group 3 cups (cat# 130-36-53 / serial# (b)(4)); cocr fem head 36mm -3.5 offset 12/14 (cat# 142-36-93 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 11 yrs postop the initial l tha, this (b)(6) y/o male patient was brought to surgery for left hip revision.X rays showed osteolysis around the cup with possible loose cup.The femur was exposed, the femoral head was elevated and removed from the stem.The stem was checked and found to be well fixed.The acetabular components were exposed, the poly liner was removed with the aid of a liner removal tool (the damage to the retuned implant will show the damage from the tool around the peripheral).The in line acetabular impactor was seated into the cup, the cup was loose, and movements allowed the cup to be removed.The acetabulum was packed with graft and reverse reamed.The patient received a new 58mm multi-hole alteon cup, with screws and a 40mm extended coverage liner.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.
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 loosening.Malalignment of the acetabular cup may have led to an increase in wear of the acetabular liner due to edge loading and/or the subsequent prosthesis wear may have contributed to particle-induced osteolysis and possible migration/loosening of the acetabular cup.However, the contributions of acetabular cup positioning and prosthesis wear to the sequence of events cannot be determined from the provided information.The most probable root cause associated with the reported event of " loosening - acetabular" 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.

• Brand Name: NV CROWN CUP CLSTR HOLE 58MM GROUP 3
• 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: 11812861
• Report Number: 1038671-2021-00231
• Device Sequence Number: 3767062
• Product Code: JDI
• UDI-Device Identifier: 10885862037046
• UDI-Public: 10885862037046
• 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: 2010
• 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): 09/13/2021

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: 01/13/2014
• Device Model Number: NV CROWN CUP CLSTR HOLE 58MM GROUP 3
• Device Catalogue Number: 180-01-58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: 75 YR
• Patient Weight: 108