MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA STAB INS SZ3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number 960442

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

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 02/10/2020

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

Surgeon reported that a patient, who has a total knee implanted 15 years ago, experienced some anterior knee pain, clunking related to possible patella issues.The patient also reported that there was an inflammation.He performed a revision, where it was discovered that the patella had some wear and had become misshapen.The patella had a groove worked into it.It could have been from a fall, according to the surgeon.Otherwise, the rest of the total knee looked good.He replaced the liner, checked that all the components were well fixed and replaced the patella button with a new one.Original surgery was (b)(6) 2005.

Manufacturer Narrative

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.H10 additional 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA STAB INS SZ3 12.5MM
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9750822
• MDR Text Key: 180762049
• Report Number: 1818910-2020-05919
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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 Catalogue Number: 960442
• Device Lot Number: 1913544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFC KEEL TIB TRAY CEM SZ3; PFC SIGMA OVAL/DOME PATELLA 3PEG 32MM; PFC*SIGMA C/S NPOR FEM RT SZ 3; PFC KEEL TIB TRAY CEM SZ3; PFC SIGMA OVAL/DOME PATELLA 3PEG 32MM; PFC*SIGMA C/S NPOR FEM RT SZ 3
• Patient Outcome(s): Required Intervention