MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP AOX INS STD+ 12.5; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129418512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	02/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Lcs litigation records alleged that plaintiff sustained serious personal injuries, was prevented from attending to his usual affairs and occupation, and has suffered and will in the future suffer pain and permanent disability.Doi: (b)(6) 2017, dor: (b)(6) 2017, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no devices were returned.Root cause undetermined.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, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient underwent orthopedic surgery on or about (b)(6), 2017 and (b)(6), 2017, and was implanted with depuy synthes devices which subsequently malfunctioned or failed, causing plaintiff injuries, debilitation and necessitating further medical interventions.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no devices were returned.Root cause undetermined 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.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.A review of complaint databases did not identify any anomalies.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot = > null.Device history batch = > null.Device history review = > null.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. .

• Brand Name: LCS COMP RP AOX INS STD+ 12.5
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8448015
• Report Number: 1818910-2019-88318
• Device Sequence Number: 3057274
• Product Code: NJL
• UDI-Device Identifier: 10603295024231
• UDI-Public: 10603295024231
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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: 129418512
• Device Lot Number: 359066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 06/03/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/16/2019; 06/17/2019
• 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: Other