MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/17/2020
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
The patient was revised to address tibial stem pain.Doi: unknown, dor: (b)(6) 2020, unknown affected side.
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: UNIVERSAL STEM 75X12MM 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: 10612931
• Report Number: 1818910-2020-21309
• Device Sequence Number: 372793
• Product Code: JWH
• UDI-Device Identifier: 10603295217817
• UDI-Public: 10603295217817
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/17/2020

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: 86-7412
• Device Catalogue Number: 867412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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: MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE CEM M/L 29MM; SIZE 3 TIBIAL PRIMARY RP INSERT 10MM; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE CEM M/L 29MM; SIZE 3 TIBIAL PRIMARY RP INSERT 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR