MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	198727121
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
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
The patient was revised to address infection.During a procedure, i & d w/ tibial insert exchange done.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: LPS UNIV TIB HIN INS XSM 21MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8200600
• Report Number: 1818910-2018-79273
• Device Sequence Number: 1952643
• Product Code: KRO
• UDI-Device Identifier: 10603295079439
• UDI-Public: 10603295079439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2018

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: 198727121
• Device Lot Number: BFA0J0L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 12/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR