MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/11/2020
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
Revision of an lcs revision due to loosening, infection and fracture (loosening and fracture are unspecified).Dor: (b)(6) 2020.
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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNIVERSAL STEM 115X16MM FLUTED
• 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: 10726929
• Report Number: 1818910-2020-23214
• Device Sequence Number: 4123808
• Product Code: NJL
• UDI-Device Identifier: 10603295217916
• UDI-Public: 10603295217916
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

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: 86-7430
• Device Catalogue Number: 867430
• Device Lot Number: 471678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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 COM POST AUG 10MM STD+; LCS COMP VVC INS STD+ 15MM; LCS COMPLETE REVFEM CEM L STD+; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED; LCS COM POST AUG 10MM STD+; LCS COMP VVC INS STD+ 15MM; LCS COMPLETE REVFEM CEM L STD+; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention