MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH 15 DEGREE LINER 28MM SZ G

Model Number	132-28-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): ceramic head 28mm +5mm neck (cat# c-28l / sn# (b)(4)).
Event or Problem Description
As reported, the patient had a hip revision due to device dislocation.Patient was last known to be in stable condition following the event.
Event or Problem Description
As reported, the 65 y/o female patient had a left hip revision due to device malfunction.Patient was last known to be in stable condition following the event.No other information available at this time.The implants will not be returned.The hospital keeps the implants that are removed.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported may have been the result of either loosened supporting ligaments surrounding the joint, hip range of motion sufficient to initiate lever-out of the femoral head, patient conditions, or a combination of the three, which lead to dislocation.However, this cannot be confirmed as the devices were not available for evaluation.(d11) concomitant device(s): - ceramic head 28mm +5mm neck (cat# c-28l / sn# (b)(6)).No information provided in the following section(s): a4, a5, and b6.The following section(s) have additional info; b5, g4, g7, h1, h2, h3, and h7.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH 15 DEGREE LINER 28MM SZ G
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9563541
• Report Number: 1038671-2020-00002
• Device Sequence Number: 16693693
• Product Code: JDI
• UDI-Device Identifier: 10885862023025
• UDI-Public: 10885862023025
• 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: 2001
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 08/05/2006
• Device Model Number: 132-28-07
• Device Catalogue Number: 132-28-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 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: 65 YR