MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 RM/LL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-08-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 02/24/2021

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

Sigma partial knee revision.

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.H10 additional narrative: 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).Investigation summary : examination of the returned device does not confirm the reported event and found no defects present.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.

• Brand Name: SIGMA HP UNI FEMORAL SZ2 RM/LL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11453977
• MDR Text Key: 238882700
• Report Number: 1818910-2021-04824
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001782
• UDI-Public: 10603295001782
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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
• Device Operator: Health Professional
• Device Model Number: 1024-08-200
• Device Catalogue Number: 102408200
• Device Lot Number: J16A89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/08/2021; 04/29/2021
• Supplement Dates FDA Received: 04/15/2021; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PALACOS CEMENT; SIGMA HP UNI FEMORAL SZ2 RM/LL; SIGMA HP UNI INS SZ1 8MM RM/LL; SIGMA HP UNI TIB TRAY SZ1 RMLL; PALACOS CEMENT; SIGMA HP UNI FEMORAL SZ2 RM/LL; SIGMA HP UNI INS SZ1 8MM RM/LL; SIGMA HP UNI TIB TRAY SZ1 RMLL
• Patient Outcome(s): Required Intervention