MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 15DEG LINER 36MM SZ H

Model Number	132-36-28
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): cocr femoral head, 36mm +0 (cn: 142-36-00, sn:(b)(4)).
Event or Problem Description
Original total right hip arthroplasty was performed on this male patient on (b)(6) 2010.The surgeon opened the joint in standard fashion and dislocated the hip.The surgeon removed old head and liner.The surgeon then implanted a new head and liner in the same sizes.This was more of a "tire change." the surgeon then relocated the hip and closed the wound.
Event or Problem Description
As reported, approximately 9 ½ years post the initial tha, a 70 y/o male patient was revised.The surgeon opened the joint in standard fashion and dislocated the hip.He removed old head and liner.He then implanted a new head and liner in the same sizes.Reportedly, this was more of a "tire change." the surgeon then relocated the hip and closed the wound.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision cannot be conclusively determined since the devices were not returned.The most likely cause is expected wear.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that as reported, approximately 9 ½ years post the initial tha, a 70 y/o male patient was revised.The surgeon opened the joint in standard fashion and dislocated the hip.He removed old head and liner.He then implanted a new head and liner in the same sizes.Reportedly, this was more of a "tire change." the surgeon then relocated the hip and closed the wound.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision cannot be conclusively determined since the devices were not returned.The most likely cause is expected wear.(d11) concomitant device(s): cocr femoral head, 36mm +0 (cn: 142-36-00, sn:(b)(6).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 15DEG LINER 36MM SZ H
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9250160
• Report Number: 1038671-2019-00541
• Device Sequence Number: 2363269
• Product Code: JDI
• UDI-Device Identifier: 10885862023391
• UDI-Public: 10885862023391
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: 510K: K05155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 11/03/2013
• Device Model Number: 132-36-28
• Device Catalogue Number: 132-36-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention