MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH CEMENTED STEM SZ 2

Model Number	132-28-06
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: (cn: 112-01-02, sn: unk) acumatch cemented stem sz 2.(cn: 132-28-00, sn: unk) 50mm gxl liner.No information provided in the following section(s): weight, race, test dates, serial number, exp date, and mfg date.
Event or Problem Description
As reported, approximately 19 ½ years postop the initial implant, this (b)(6) y/o female patient experienced a left hip revision because the hip fractured.The surgeon believes that osteolysis and poly wear lead to a gradual weakening of the bone and eventual fracture.The hip was revised due to a peri prosthetic fracture.The surgeon chose to replace with competitor¿s devices.In accordance with hospital policy we are unable to return explants.Patient was last known to be in stable condition following the event.Weight (b)(6) kgs and no additional medical history provided.
Additional Manufacturer Narrative
(h3) the evaluation noted that the revision was likely the result of may have been the result of the orientation of the acetabular cup, edge loading/impingement, or a combination of the two, which led to prosthesis wear and osteolysis.The prosthesis wear and osteolysis may have resulted in gradual weakening of the bone, and resulted in a bone fracture.However, this cannot be confirmed as the devices were not returned for evaluation.Concomitant devices: - (cn: 112-01-02, sn: unk) acumatch cemented stem sz 2 - (cn: 100-28-00, sn: unk) 28mm cocr head no information provided in the following section(s): a4, a5, b6, d4 (serial number, exp date), and h4.The following section(s) have additional info: d4 (catalog number, and udi number), g4, g7, h1, h2, h3, and h7.Section h11: corrections made in the following section(s): (d4) (catalog number, udi number).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH CEMENTED STEM SZ 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10177018
• Report Number: 1038671-2020-00314
• Device Sequence Number: 19410628
• Product Code: JDI
• UDI-Device Identifier: 10885862023018
• UDI-Public: 10885862023018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 132-28-06
• Device Catalogue Number: 132-28-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: 78 YR