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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP TROCHLEA SZ3 RT; EARLY INTERVENTION : KNEE FEMORAL
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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP TROCHLEA SZ3 RT; EARLY INTERVENTION : KNEE FEMORAL Back to Search Results
Catalog Number 102404300
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 02/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Pain.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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
SIGMA HP TROCHLEA SZ3 RT
Common Device Name
EARLY INTERVENTION : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7316093
Report Number1818910-2018-54587
Device Sequence Number1605829
Product Code HRY
UDI-Device Identifier10603295001683
UDI-Public10603295001683
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K061648
Number of Events Summarized1
Summary Report (Y/N)N
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) 02/06/2018
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 Number102404300
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/06/2018
Supplement Date Received by Manufacturer04/16/2018
Initial Report FDA Received Date03/06/2018
Supplement Report FDA Received Date04/23/2018
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;
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