MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPER CEM STEM 13X90; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-6468
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); No Code Available (3191)
Date of Event	09/30/2020
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
Clinical adverse event received for left knee swelling/hemarthrosis.Event is serious and is considered moderate.Event is possibly related to device and there is a remote possibility that the event is related to procedure.Date of implantation: (b)(6) 2019.Date of revision (insert): (b)(6) 2020.Date of event (onset): (b)(6) 2020.(left knee).Treatment: surgical irrigation & debridement, with no revision of products.
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 which has not been investigated or verified 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.No code available (3191) is used to capture wound secretion.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Added patient codes wound secretion (wound draining was reported during the clinic visit on (b)(6) 2020) and infection (revision of the insert was done on (b)(6) 2020 due to infection.
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: TAPER CEM STEM 13X90
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10691171
• Report Number: 1818910-2020-22615
• Device Sequence Number: 3204694
• Product Code: JWH
• UDI-Device Identifier: 10603295217176
• UDI-Public: 10603295217176
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2020

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: 86-6468
• Device Catalogue Number: 866468
• Device Lot Number: D17063312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/19/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/02/2020; 11/23/2020
• 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: DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY S2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG RP AOX STB INS SZ2.5 22.5; SIG TIB CEM STM 13X60 2/2.5/3; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ2.5 L; TAPER CEM STEM 13X90
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 50