MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH 15 DEGREE LINER 32MM SIZE G

Catalog Number	132-32-07
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinical evaluation noted upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event is the patient¿s underlying condition concomitant device(s): 32mm +0 femoral head (cn: c-32m, sn: (b)(4)).
Event or Problem Description
Original right total hip arthroplasty on this female patient was performed on (b)(6) 2004.Patient was showing minor instability in the hip to the surgeon planned to revise the hip and upsize the femoral head and change out he liner.The surgeon opened the joint in standard fashion.The surgeon removed the femoral head implant.The surgeon then removed the acetabular liner implant.The surgeon trialed the sizes then implanted the final implants and closed the hip in standard fashion.The patient left the operating room in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned to exactech.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH 15 DEGREE LINER 32MM SIZE G
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9174876
• Report Number: 1038671-2019-00504
• Device Sequence Number: 3107578
• Product Code: JDI
• UDI-Device Identifier: 10885862023209
• UDI-Public: 10885862023209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 11/02/2008
• Device Catalogue Number: 132-32-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/10/2019
• 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: 81 YR