MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number 196050400

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 01/03/2018

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

Right knee revised on (b)(6) 2018, to address aseptic loosening of both the tibial base plate and the femur components at unspecified interfaces.There was reported extensive osteolysis affecting both the proximal tibia and distal femur bone beneath the implants.Femur, tibial base plate, and tibial insert components were revised; patella component was preserved.Knee revised to a competitor system, apart from the patella.Product and lot code information for the knee indicate this is a depuy sigma system right knee, not attune, as alleged.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIGMA PS CEM FEM SZ4 R
• Type of Device: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8227259
• MDR Text Key: 132391080
• Report Number: 1818910-2019-80162
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295075141
• UDI-Public: 10603295075141
• Combination Product (y/n): N
• PMA/PMN Number: K073529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 196050400
• Device Lot Number: 3361118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR