MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; INTEGRIP CC, CLUSTER 48MM, G1

Model Number	186-01-48
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: acetabular liner (cat# 138-32-51); femoral stem (cat# 164-01-10); femoral head (cat# 170-32-03).
Event or Problem Description
As reported, approximately 3.5 years post op the initial left tha, this patient was revised due to tantalum particulate debris third body wear of gxl poly.This (b)(6)y/o (b)(6)lb, 5¿3¿ female has a history of avascular necrosis, hypertension, and lupus.Devices will not return.All available information has been received at this time.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of the orientation of the acetabular cup, edge loading/impingement, patient conditions, or a combination of the three, which led to polyethylene wear.However, this cannot be confirmed as the explants were not available for evaluation.Concomitant devices: - integrip cc, cluster 48mm, g1 (cat# 186-01-48, sn: (b)(4) ).- femoral stem (cat# 164-01-10, sn: (b)(4) ).- femoral head (cat# 170-32-03, sn: (b)(4) )).
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of the orientation of the acetabular cup, edge loading/impingement, patient conditions, or a combination of the three, which led to polyethylene wear.However, this cannot be confirmed as the explants were not available for evaluation.Concomitant devices: acetabular liner (cat# 138-32-51, sn: (b)(4).Femoral stem (cat# 164-01-10, sn: (b)(4).Femoral head (cat# 170-32-03, sn: (b)(4).

• Brand Name: NOVATION
• Common Device Name: INTEGRIP CC, CLUSTER 48MM, G1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9868088
• Report Number: 1038671-2020-00259
• Device Sequence Number: 14190963
• Product Code: JDI
• UDI-Device Identifier: 10885862038753
• UDI-Public: 10885862038753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2017
• Device Model Number: 186-01-48
• Device Catalogue Number: 186-01-48
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 04/23/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/22/2020; 04/23/2020
• 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
• Patient Age: 38 YR
• Patient Weight: 67