MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7428
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/03/2020
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 notification received for right knee revision to address implant loosening and implant fracture.Date of implantation: unk/unk/1992, date of revision #1: (b)(6) 2016 (insert, patella), date of revision #2: (b)(6) 2016 (femur, tibial base plate, insert), date of revision #3: (b)(6) 2020, (right knee).Treatment: revision of femur construct, hinged tibial insert, and tibia construct implants.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNIVERSAL STEM 115X14MM 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
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10487946
• Report Number: 1818910-2020-19357
• Device Sequence Number: 2726708
• Product Code: JWH
• UDI-Device Identifier: 10603295217909
• UDI-Public: 10603295217909
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 86-7428
• Device Catalogue Number: 867428
• Device Lot Number: 667461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; LPS DISTAL FEM COMP XSM RT (EX PKT); LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 30MM; LPS UNIV TIB HIN INS XSM 18MM; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 61MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; TAPER CEM STEM 13X90; UNIVERSAL FEM SLV DIS POR 40MM; (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; (STRYKER) SIMPLEX BONE CEMENT: 6191-1-001/RGX088; LPS DISTAL FEM COMP XSM RT (EX PKT); LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 30MM; LPS UNIV TIB HIN INS XSM 18MM; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 61MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; TAPER CEM STEM 13X90; UNIVERSAL FEM SLV DIS POR 40MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White