MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS M BRDG BRG STD+/LG 10.0; LCS : KNEE TIBIAL INSERT

Catalog Number	127824000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional narrative: 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
Poly wear.Patient consequence? :yes.Patient consequence description:poly change.Action taken for procedure:action for new poly.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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 M BRDG BRG STD+/LG 10.0
• Common Device Name: LCS : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7800930
• Report Number: 1818910-2018-67231
• Device Sequence Number: 2365947
• Product Code: NJL
• UDI-Device Identifier: 10603295020394
• UDI-Public: 10603295020394
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: 127824000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1