MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP NO HOLE 58MM GROUP 3; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	180-00-58
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 135 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear with acetabular osteolysis, necrotic bone, pain, and suffering.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: 2012783 148-36-00 - 12/14 zirconia head 36mm rep by 170-36-00.2400587 164-01-13 - element-stem, collarless w/ha, std offset, sz 13.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP NO HOLE 58MM GROUP 3
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19693365
• Report Number: 1038671-2024-02315
• Device Sequence Number: 7156019
• Product Code: JDH
• UDI-Device Identifier: 10885862036896
• UDI-Public: 10885862036896
• 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: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: 09/05/2015
• Device Catalogue Number: 180-00-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/08/2024
• Date Device Manufactured: 09/07/2010
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown