MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMPLETE FEM CEM L STD; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129402040
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	10/01/2018
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
It was reported that when opening the protective cover on the top of the implant, part of the covering tore and cut a portion of the cover still on the plastic carrier.This kept the implant from being removed from the plastic container.The surgeon tried to pull the tab on the implant and tore it too.After this, the surgeon did not feel he could transfer the implant onto the sterile field safely.He did not want to contaminate the field.
Additional Manufacturer Narrative
Product complaint # :(b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary evaluation of the returned device/packaging components confirms the reported event.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.Device history lot product code (b)(4), lot number 8726076 device history review product code (b)(4), work order 8726076 was manufactured on (b)(4) 2018.10 parts were manufactured per specification and all raw materials met specification.There are no ncs or deviations associated with this lot.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 CEM L STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7956026
• Report Number: 1818910-2018-72147
• Device Sequence Number: 16471713
• Product Code: NJL
• UDI-Device Identifier: 10603295021629
• UDI-Public: 10603295021629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 129402040
• Device Lot Number: 8726076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/29/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/07/2018; 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR