MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LPS UNIV TIB HIN INS SM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	198727223
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
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
Revision due to pain and infection.Doi: unk.(b)(6) 2017.Left knee.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Please disregard this medwatch submission as it was reported in error.It is not reasonable to conclude that the device contributed to the patient's infection, 3+ months after implantation.
Event or Problem Description
Reported in error.

• Brand Name: LPS UNIV TIB HIN INS SM 23MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7211880
• Report Number: 1818910-2018-51768
• Device Sequence Number: 16433839
• Product Code: KRO
• UDI-Device Identifier: 10603295079538
• UDI-Public: 10603295079538
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2017

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: 198727223
• Device Lot Number: 678260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2017
• Supplement Date Received by Manufacturer: 12/30/2017
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 01/24/2018
• 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: 87 YR
• Patient Weight: 1