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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISTAL FEM COMP XSM LT; LPS AND S-ROM : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US LPS DISTAL FEM COMP XSM LT; LPS AND S-ROM : KNEE FEMORAL Back to Search Results
Model Number 1987-13-105
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 03/04/2021
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
Patient received left knee revision of the stem and femoral component to treat thigh discomfort associated with loosening of the components at the cement to implant interface.Surgeon said patient had their knee revised back on (b)(6) 2020.Surgeon preformed the revision and just exchanged the poly from a 26mm to 28mm.Surgeon didn't have access to the previous procedure dates prior to surgeon revision.Doi: (b)(6) 2019 (stem and femoral), doi: (b)(6) 2020 (insert and hinge pin), dor: (b)(6) 2021, left 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: no lot information available.
 
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Brand Name
LPS DISTAL FEM COMP XSM LT
Common Device Name
LPS AND S-ROM : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11554774
Report Number1818910-2021-05833
Device Sequence Number3932092
Product Code JWH
UDI-Device Identifier10603295078685
UDI-Public10603295078685
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K063686
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
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) 03/04/2021
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? Yes
Operator of Device Health Professional
Device Model Number1987-13-105
Device Catalogue Number198713105
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/04/2021
Supplement Date Received by Manufacturer04/14/2021
Initial Report FDA Received Date03/23/2021
Supplement Report FDA Received Date04/15/2021
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
LPS CEMENTED STEM 14X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 28MM; LPS XX-SM HINGE PIN; LPS CEMENTED STEM 14X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 28MM; LPS XX-SM HINGE PIN
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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