MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-200
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On sunday the 13th in the surgery process the j&j inhouse instrumentalist detected that the product sigma ps femur sz2 r (code 196050200 and lot: 8014599), had the plastic protector open.After surgical procedure has advanced 10 minutes and before placing the definitive prosthesis asks the circulator to pass the prostheses and they realize that when they opened the box of the femoral component they were open and therefore were not sterile, this caused discomfort with the surgeon.So immediately notify the j&j executive to urgently manage your replacement.This claim was accepted by the deliver team as a distribution claim.This delay in replacing the product in the institution caused the patient to be exposed at an additional time to the anesthesia of the planned.  date of awareness of adverse incident: november 5.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 will be filed as appropriate.

• Brand Name: SIGMA PS CEM FEM SZ2 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9398288
• Report Number: 1818910-2019-119155
• Device Sequence Number: 19510170
• Product Code: JWH
• UDI-Device Identifier: 10603295075110
• UDI-Public: 10603295075110
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1960-50-200
• Device Catalogue Number: 196050200
• Device Lot Number: 8014599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1