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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 30MM; LPS AND S-ROM : KNEE ACCESSORY
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DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 30MM; LPS AND S-ROM : KNEE ACCESSORY Back to Search Results
Model Number 1987-07-030
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/17/2021
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
It was reported that the patient's quad tendon was ruptured and so upon repair these implants were replaced.Doi: (b)(6) 2020; dor: (b)(6) 2021; right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
LPS SEGMENTAL COMPONENT 30MM
Common Device Name
LPS AND S-ROM : KNEE ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11247111
Report Number1818910-2021-02013
Device Sequence Number14343460
Product Code JWH
UDI-Device Identifier10603295078524
UDI-Public10603295078524
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K033959
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/17/2021
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 Model Number1987-07-030
Device Catalogue Number198707030
Device Lot NumberJ8748P
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/17/2021
Supplement Date Received by Manufacturer02/24/2021
Initial Report FDA Received Date01/28/2021
Supplement Report FDA Received Date02/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE REV LPS INSRT XXSM 12MM; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 30MM; LPS XX-SM HINGE PIN; ATTUNE REV LPS INSRT XXSM 12MM; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 30MM; LPS XX-SM HINGE PIN
Outcome Attributed to Adverse Event Required Intervention;
Patient Age50 YR
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