MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH LAT LINER 28MM 54/56MM

Model Number	138-28-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, this (b)(6) y/o male patient present to the surgeon with complaints of hip instability.A revision was completed on (b)(6) 2020.The initial date of the hip implants is unknown.The patient was last known to be in stable condition.
Additional Manufacturer Narrative
(h3) the evaluation noted in the revision as reported, this 51 y/o male patient presented to the surgeon with complaints of left hip instability.A revision was completed on (b)(6) 2020.The initial date of the hip implants is unknown.The patient was last known to be in stable condition.The explanted poly was lost by the facility.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.Upon review of the returned images of the removed liner, it appears that the liner may have begun to dislocate and became impinged as a result, leading to instability.No information provided in the following section(s): d4 (serial number and expiration date).
Event or Problem Description
As reported, this 51 y/o male patient presented to the surgeon with complaints of left hip instability.A revision was completed on (b)(6) 2020.The initial date of the hip implants is unknown.The patient was last known to be in stable condition.The explanted poly was lost by the facility.Pictures of removed damaged poly received.Instability and loosening of implanted components is a known event associated with joint replacement therapy.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.Upon review of the returned images of the removed liner, it appears that the liner may have begun to dislocate and became impinged as a result, leading to the instability.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH LAT LINER 28MM 54/56MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9608322
• Report Number: 1038671-2020-00007
• Device Sequence Number: 585015
• Product Code: JDI
• UDI-Device Identifier: 10885862024541
• UDI-Public: 10885862024541
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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 Model Number: 138-28-08
• Device Catalogue Number: 138-28-08
• Device Lot Number: 7759-001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: 51 YR