Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP TROCHLEA SZ1 LT; EARLY INTERVENTION : KNEE FEMORAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US SIGMA HP TROCHLEA SZ1 LT; EARLY INTERVENTION : KNEE FEMORAL Back to Search Results
Model Number 1024-03-100
Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Date 01/28/2022
Event Type  Injury  
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 Description
Patient underwent primary patella femoral joint replacement in (b)(6) 2015.(b)(6) hospital.Patient has complained that this pf joint has never felt good and has been painful since time index surgery.A decision was made to revise the pf joint to a total knee replacement.On opening the knee, the femoral component was found to be loose.Progression on disease was also found in the other condyles.The femoral component as well as the insert patella component was removed and a total joint i planted.((b)(6) hospital, (b)(6) 2022).Depuy cement was not utilised.The femoral component was loose at the cement bone interface with the component coming loose with the cement still adhered to the underside.Doi: (b)(6) 2015; dor: (b)(6) 2022; unknown knee.
 
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 Description
Patient underwent primary patella femoral joint replacement in (b)(6) 2015.(b)(6) hospital.Patient has complained that this pf joint has never felt good and has been painful since time index surgery.A decision was made to revise the pf joint to a total knee replacement.On opening the knee, the femoral component was found to be loose.Progression on disease was also found in the other condyles.The femoral component as well as the insert patella component was removed and a total joint i planted.((b)(6) hospital, (b)(6) 2022).Depuy cement was not utilised.The femoral component was loose at the cement bone interface with the component coming loose with the cement still adhered to the underside.Doi: (b)(6) 2015; dor: (b)(6) 2022; unknown knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this complaint was received for investigation.The photo investigation cannot confirm the reported allegation.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIGMA HP TROCHLEA SZ1 LT
Type of Device
EARLY INTERVENTION : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13498070
MDR Text Key285387522
Report Number1818910-2022-02569
Device Sequence Number1
Product Code KRR
UDI-Device Identifier10603295001614
UDI-Public10603295001614
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1024-03-100
Device Catalogue Number102403100
Device Lot Number192158
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PFC SIGMA INSET PAT 25MM; SIGMA HP TROCHLEA SZ1 LT; UNK BONE CEMENT
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-