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

Catalog Number	180-01-56
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint Laxity (4526)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) - 164-01-14 - element-stem, collarless w/ha, std offset, sz 14.(b)(6) - 170-40-03 - biolox delta femoral head 40mm 0d, +3.5mm.
Event or Problem Description
As reported, approximately 7 years and 5 months post the initial tha, the patient presented back to the surgeon's office with complaints of their left hip.The patient reported pain, instability, and dissatisfaction.The patient had a recalled hip liner and it was shown on the x-r ay to have wear and femoral head migration within the acetabular implant.The patient was scheduled for left hip revision possible poly liner and femoral head swap vs.Full revision.The patient underwent left hip revision.During the revision, the patient presented with excessive hip poly liner wear, and the poly liner was fractured.The femoral head was contacting the metal cup and created metallosis within the hip joint capsule.There was osteolysis behind the acetabular cup and the implanted presented to be loose.The acetabular cup was removed, the hip joint was debrided from metallosis tissue and bone, and the patient required an allograft femoral head bone grafting substitute within the acetabulum.A new competitor g7 multi-hole cup was implanted with screws and a lateralized hip liner.A 36mm +10 mm head was implanted to match the competitor components.The surgeon had to make up leg length with +10 and a lateralized liner due to the metalization of the final construct after removal and revision re-implant.There was a 15-30 minute delay and no adverse events as a result.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19997011
• Report Number: 1038671-2024-02878
• Device Sequence Number: 7060839
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: 09/19/2021
• 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: 05/03/2024
• Initial Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 09/20/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male