MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number 960101

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

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

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

(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.Device history lot: null.Device history batch: null.Device history review: null.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. .

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8227307
• MDR Text Key: 132393021
• Report Number: 1818910-2019-80165
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232612
• UDI-Public: 10603295232612
• Combination Product (y/n): N
• PMA/PMN Number: K961685
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2017
• Device Catalogue Number: 960101
• Device Lot Number: D12021118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR