MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ3 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Model Number 1024-52-300

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

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 during a routine sigma uni knee, it was discovered that the poly insert would not seat appropriately into the metal tibial tray and loosening of the poly insert from metal tibial tray.Surgeon noticed it didn't "sit" like normal and could easily elevate it out of the tray.Opened another and it was better, but not perfect causing him to think that maybe there was something wrong with the metal tray.At this point surgeon decided it was good enough and didn¿t want to make things worse by explanting the entire construct.5 minutes surgical delay.No further patient information available.

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.

• Brand Name: SIGMA HP UNI TIB TRAY SZ3 RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11732281
• MDR Text Key: 247532338
• Report Number: 1818910-2021-08877
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002390
• UDI-Public: 10603295002390
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-52-300
• Device Catalogue Number: 102452300
• Device Lot Number: J69Y97
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CEMENT; SIGMA HP UNI FEMORAL SZ3 RM/LL; SIGMA HP UNI INS SZ3 7MM RM/LL; SIGMA HP UNI INS SZ3 7MM RM/LL; COMPETITOR CEMENT; SIGMA HP UNI FEMORAL SZ3 RM/LL; SIGMA HP UNI INS SZ3 7 MM RM/LL; SIGMA HP UNI INS SZ3 7 MM RM/LL
• Patient Age: 51 YR