MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 LCS COMPLETE FEM POR R LG; KNEE FEMORAL

Catalog Number	129403060
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
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
The two transparent casings which house the implant were tightly stuck together resulting in the scrub nurse struggling to remove the inner sterile case.The tab the scrub nurse uses to remove the inner casing broke off.The scrub nurse then had to use a forceps to remove.Doi: (b)(6) 2017.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the reported event has been evaluated and will be monitored.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.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: LCS COMPLETE FEM POR R LG
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7133033
• Report Number: 1818910-2017-52121
• Device Sequence Number: 1119405
• Product Code: NJL
• UDI-Device Identifier: 10603295021711
• UDI-Public: 10603295021711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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 Catalogue Number: 129403060
• Device Lot Number: 8625724
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1