MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H

Model Number	138-36-28
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: acumatch c-series s/o cemented stem 12/14 sz 4, 116-01-04, 0847890.Cocr fem head 36mm +3.5mm 12/14, 142-36-03, 0952590.
Event or Problem Description
As reported, approximately 13 years postop the initial tha this (b)(6) female patient was revise due to developing an infection not related to implants.Patient then started to complain of hip pain.A revision was performed (b)(6) 2020.Stem, liner and head removed.Patient was last known to be in stable condition following the event.Devices not returning due to hospital policy.
Additional Manufacturer Narrative
The evaluation of the revision based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition, specifically the reported infection that was not related to the devices.(d11) concomitant devices: - acumatch c-series s/o cemented stem 12/14 sz 4, 116-01-04, (b)(4).- cocr fem head 36mm +3.5mm 12/14, 142-36-03, (b)(4).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10419762
• Report Number: 1038671-2020-00490
• Device Sequence Number: 3190315
• Product Code: JDI
• UDI-Device Identifier: 10885862024824
• UDI-Public: 10885862024824
• 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: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 01/09/2010
• Device Model Number: 138-36-28
• Device Catalogue Number: 138-36-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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: 88 YR