MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number 96-0103

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/11/2020

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

Patient was revised due to patella pegs were fractured and loosening of the patellar component at the cement to implant interface.Unknown cement was used.Tibial poly exchange was performed.Doi: (b)(6) 2013 dor: (b)(6) 2020 left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: (b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

• 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: 10453958
• MDR Text Key: 204396493
• Report Number: 1818910-2020-18779
• Device Sequence Number: 1
• Product Code: JWJ
• UDI-Device Identifier: 10603295232636
• UDI-Public: 10603295232636
• Combination Product (y/n): N
• PMA/PMN Number: K96168
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-0103
• Device Catalogue Number: 960103
• Device Lot Number: D12062529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA XLKCVD PLUS INS 4 12.5MM; SIGMA XLKCVD PLUS INS 4 12.5MM
• Patient Outcome(s): Required Intervention