MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP AOX INS STD+ 17.5; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-18-517
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/20/2020
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 primary surgery was of the left knee on (b)(6) 2020.Patient developed a hematoma.So surgeon performed an i&d on (b)(6) 2020 and exchanged the poly liner.Attached is the dgr from original surgery with the remaining components.I have no further information to add.Did the patient experience a post-op device malfunction?: no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing?: yes, did the patient require revision surgery or hardware removal?: yes, facility name of original implant: dch, was device explanted?: true, hardware/explant removal due to: hematoma and need to perform a complete irrigation, did patient require revision surgery?: true, if yes, date of revision surgery: 7/20/2020, reason for revision surgery: evacuation of a hematoma, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?: hematoma, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe: evacuation of hematoma, is the patient part of a clinical study: no, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: LCS COMP RP AOX INS STD+ 17.5
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10351382
• Report Number: 1818910-2020-17290
• Device Sequence Number: 16835927
• Product Code: NJL
• UDI-Device Identifier: 10603295024255
• UDI-Public: 10603295024255
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 1294-18-517
• Device Catalogue Number: 129418517
• Device Lot Number: HU1032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: LCS COMP RP AOX INS STD+ 17.5; LCS COMPLETE FEM POR L STD+; LCS COMPLETE M/B PAT POR STD+; MBT POR TIBIAL TRAY SZ4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR