MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH CLUSTER CUP POROUS COATED 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	ACUMATCH CLUSTER CUP POROUS COATED 52MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: acumatch cluster cup porous coated 52mm (cat# 120-01-52/ serial# (b)(4)).Acumatch gxl 15deg liner 32mm sz g (cat# 132-32-27 / serial# (b)(4)).The evaluation noted that revision reported was likely the result of a deterioration of the bond between the acetabular cup and the bone after being implanted for approximately 15 years, which resulted in aseptic (non-infected) acetabular cup loosening.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "loosening - acetabular" is weakened integration of the acetabular component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Event or Problem Description
As reported, a revision of only the left femoral head was completed due to loosening for this (b)(6) female patient.The cup was loose.The surgeon implanted femoral head, 28mm +10.All components on acetabular side were revised to a competitor.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation as hospital threw away.

• Brand Name: ACUMATCH CLUSTER CUP POROUS COATED 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11407130
• Report Number: 1038671-2021-00090
• Device Sequence Number: 3545207
• Product Code: JDI
• UDI-Device Identifier: 10885862019738
• UDI-Public: 10885862019738
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 07/16/2016
• Device Model Number: ACUMATCH CLUSTER CUP POROUS COATED 52MM
• Device Catalogue Number: 120-01-52
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/03/2021
• 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: 85 YR