MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS ROT PLAT BRNG LG+/10MM; LCS : KNEE TIBIAL INSERT

Catalog Number	117861000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received.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 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
Revision surgery is planned to replace the implanted tibial insert for a new device.Revision surgery will be done as soon as the customer specific device is available, the reason of the revision: the liner worn.

• Brand Name: LCS ROT PLAT BRNG LG+/10MM
• Common Device Name: LCS : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8055299
• Report Number: 1818910-2018-75083
• Device Sequence Number: 1484828
• Product Code: NJL
• UDI-Device Identifier: 10603295008026
• UDI-Public: 10603295008026
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 117861000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 100