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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 9MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 9MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT Back to Search Results
Model Number 1024-54-509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/10/2021
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
It was reported that the patient had a uni knee done back on (b)(6).He came in to the office with a red swollen knee.The surgeon washed out the knee and the poly was swapped.Doi: (b)(6) 2021.Dor: (b)(6) 2021, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the infection (e19).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
On (b)(6) 2021, the patient underwent a right knee revision with tibial insert exchange and irrigation and debridement to address a deep infection and swelling.There were no indicated intra-operative complications.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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
SIGMA HP UNI INS SZ5 9MM RM/LL
Type of Device
EARLY INTERVENTION : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12413157
MDR Text Key269507683
Report Number1818910-2021-19155
Device Sequence Number1
Product Code HRY
UDI-Device Identifier10603295002956
UDI-Public10603295002956
Combination Product (y/n)N
PMA/PMN Number
K070267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1024-54-509
Device Catalogue Number102454509
Device Lot NumberJ8259T
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SIGMA HP UNI INS SZ5 9MM RM/LL; SIGMA HP UNI INS SZ5 9MM RM/LL
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight107
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