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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG RP AOX CRV INS SZ3 17.5; TIBIAL INSERT
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DEPUY ORTHOPAEDICS, INC. 1818910 SIG RP AOX CRV INS SZ3 17.5; TIBIAL INSERT Back to Search Results
Catalog Number 196192034
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 10/31/2017
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
The patient had an mcl injury after the original tka.The mcl was repaired and a thicker insert was put in on (b)(6) 2016.The patient had pain and instability some time after the mcl, so the implants were removed and a rev construct was implanted.
 
Additional Manufacturer Narrative
This is a duplicate report of (b)(4).1818910-2017-50434 is being retracted as it is a report duplication.(b)(4) will be kept for investigation purposes.
 
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Brand Name
SIG RP AOX CRV INS SZ3 17.5
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
MDR Report Key7069897
Report Number1818910-2017-50434
Device Sequence Number16413898
Product Code NJL
UDI-Device Identifier10603295076193
UDI-Public10603295076193
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/31/2017
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 Number196192034
Device Lot Number7960526
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/31/2017
Supplement Date Received by Manufacturer08/31/2018
Initial Report FDA Received Date11/29/2017
Supplement Report FDA Received Date09/03/2018
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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