MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Date of Event	04/24/2020
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
Patient was treated with a knee replacement on the (b)(6) 2019.Patient was admitted to hospital due to an inflammation in the knee.Revision surgery planned for the (b)(6) 2020.No further information available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  h6 patient code: no code available (3191) reported from the initial medwatch will be corrected to device revision or replacement.

• Brand Name: LPS UNIV TIB HIN INS XSM 12MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10014838
• Report Number: 1818910-2020-11556
• Device Sequence Number: 2078021
• Product Code: KRO
• UDI-Device Identifier: 10603295079392
• UDI-Public: 10603295079392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2020

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 Model Number: 1987-27-112
• Device Catalogue Number: 198727112
• Device Lot Number: HH3011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 06/08/2020; 07/09/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/12/2020; 06/09/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR BONE CEMENT; LPS UNIV TIB HIN INS XSM 12MM; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 45MM; P.F.C.* TIB STM EXT 4/5/6 30MM; SROM NRH FEM W/PIN XSMRT 66X58; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 115X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR