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MAUDE Adverse Event Report: EXACTECH, INC. LINER
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EXACTECH, INC. LINER
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Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems
Pain (1994); Pain (1994); Joint Disorder (2373)
Event Date
07/31/2018
Event Type
Injury
Manufacturer Narrative
Pending evaluation.
Event Description
Revision due to pain and joint instability.
Manufacturer Narrative
The engineering evaluation noted the revision was likely the result of loose supporting ligaments, which led to joint instability and pain.
Event Description
Revision due to pain and joint instability.
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Brand Name
LINER
Type of Device
LINER
Manufacturer
(Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key
7757303
MDR Text Key
116250163
Report Number
1038617-2018-00649
Device Sequence Number
0
Product Code
KWT
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Manufacturer
Source Type
health professional
Type of Report
Initial,Followup
Report Date
02/06/2019
2
Devices were Involved in the Event:
1
2
2
Patient was Involved in the Event
Date FDA Received
08/07/2018
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
Health Professional
Was Device Available for Evaluation?
No
Date Manufacturer Received
08/06/2018
Is This a Reprocessed and Reused Single-Use Device?
No
Patient Sequence Number
0
Patient Outcome(s)
Required Intervention;
Patient Age
68 YR
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