MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G

Model Number	138-28-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): cocr fem head 28mm +10 offset 12/14 (cat# 142-28-10 / sn# (b)(4)), acumatch cluster cup porous coated 52mm (cat# 120-01-52 / sn# (b)(4)), bone screw 6.5mm dia x 35mm long (cat# 120-65-35 / sn# (b)(4)).No information provided in the following section(s): weight, ethnicity, and implant date.
Event or Problem Description
As reported, this (b)(6) male was initially implanted on (b)(6) 2005.There were revisions on (b)(6) 2017, reported in report #1038671-2019-00509 and on (b)(6) 2019, reported in report #1038671-2019-00499.In this revision, the surgeon decided to remove the acetabular cup and reamed up a few sizes and implanted a competitor¿s revision cup and implanted a liner in to the cup.The surgeon trialed femoral heads and used one that made the hip very stable and then implanted the femoral head and then closed the joint in standard fashion.The patient left the or in stable condition.Devices will not be returned per hospital policy.
Event or Problem Description
As reported, this 76 y/o male was initially implanted on (b)(6) 05.There was a revision on (b)(6) 2017 the reason was not reported, that was submitted in report #1038671-2019-00509 (case# 00001501).On (b)(6) 2019 and revision occurred due to dislocation and was reported in report #1038671-2019-00499 (case# 00001499).In this revision on (b)(6) 2019 (case# 00001893), the surgeon decided to remove the acetabular cup, reamed up a few sizes, implanted a competitor¿s revision cup and implanted a liner into the cup.The surgeon trialed femoral heads and used one that made the hip very stable and then implanted the femoral head and then closed the joint in standard fashion.The patient left the or in stable condition.Devices will not be returned per hospital policy.The reason for the revision was not reported.
Additional Manufacturer Narrative
(h3) the evaluation noted in the revision reported that upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is unknown at this time however is most likely patient conditions.(d11) concomitant device(s): - cocr fem head 28mm +10 offset 12/14 (cat# 142-28-10 / sn# (b)(6)).- acumatch cluster cup porous coated 52mm (cat# 120-01-52 / sn# (b)(6)).- bone screw 6.5mm dia x 35mm long (cat# 120-65-35 / sn# (b)(6)).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9504006
• Report Number: 1038671-2019-00616
• Device Sequence Number: 11089013
• Product Code: JDI
• UDI-Device Identifier: 10885862024602
• UDI-Public: 10885862024602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 02/27/2015
• Device Model Number: 138-28-27
• Device Catalogue Number: 138-28-27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 09/05/2020
• 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: 76 YR