MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 52MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-52
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-02364 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02364 the most likely underlying cause for the revision reported is a combination of risk factors specified such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) including but not limited to use error and being implanted for more than 10 years.The acetabular cup loosening may have been the result of an insufficient bond between the acetabular cup and the acetabular bone.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that the patient had an initial right total hip arthroplasty and then approximately 129 months later experienced a revision surgery.Failed right tha (acetabular implants).Severe poly wear with soft tissue damage around the hip joint.Femoral stem was stable and well fixed ¿ therefore did not revise.Cup was easily removed ¿ it was not well fixed.The backside of the cup had no bone in-growth.There was extensive soft tissue debris throughout the kneed joint consistent with synovitis from a polyethylene reaction to the tissues.This was tiny, small balls of light brown synovium along with a ¿pseudo-capsule¿ of dense soft tissue rind.Examination of polyethylene ¿ excessive wear was present with signs of oxidation / yellow discoloration, pitting, cracking and delamination of the poly.Severe eccentric superior lateral poly wear.Patient reversed from anesthesia and sent to pacu in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No other information is available.

• Brand Name: NV CROWN CUP CLSTR HOLE 52MM GROUP 2
• 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
• MDR Report Key: 20774973
• Report Number: 1038671-2024-04496
• Device Sequence Number: 8004642
• Product Code: JDI
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 08/05/2017
• Device Catalogue Number: 180-01-52
• 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: 08/22/2023
• Initial Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 08/07/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female