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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AMK CONS TIB INS SIZE 3 10MM; AMK : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS, INC. 1818910 AMK CONS TIB INS SIZE 3 10MM; AMK : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 168851025
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Patient was revise to address poly liner wear.Doi: (b)(6) 2010; dor: (b)(6) 2018; left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
AMK CONS TIB INS SIZE 3 10MM
Common Device Name
AMK : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7224399
Report Number1818910-2018-52255
Device Sequence Number984045
Product Code HRY
UDI-Device Identifier10603295067146
UDI-Public10603295067146
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K944538
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 01/10/2018
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 Catalogue Number168851025
Device Lot NumberD48JF1000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/10/2018
Supplement Date Received by Manufacturer04/11/2018
Initial Report FDA Received Date01/29/2018
Supplement Report FDA Received Date04/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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