MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM POR R STD+; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-03-050
Medical Device Problem Codes	Difficult to Open or Close (2921); Device Difficult to Maintain (3134)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Lcs femoral implant was being opened by nursing staff, the inner sterile packaging was stuck inside the outer packaging.Scrub nurse needed to remove the paper covering of the internal packaging to access the femoral component.The packaging is still stuck together and available for examination if required.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no product or packaging was returned.We were provided with a photo of the tyvek that confirmed the incident and a photo of the label to identify the product.No corrective actions were deemed necessary as the cause of the reported issue was undetermined.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: LCS COMPLETE FEM POR R STD+
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8962272
• Report Number: 1818910-2019-103113
• Device Sequence Number: 3147133
• Product Code: NJL
• UDI-Device Identifier: 10603295021704
• UDI-Public: 10603295021704
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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,Followup
• Report Date (Section B): 08/16/2019

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: 1294-03-050
• Device Catalogue Number: 129403050
• Device Lot Number: 9018246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 07/15/2020
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/17/2019; 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1