MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 150X16MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7444
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2021
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
(b)(4).The patient was revised to address loosening of the femoral component and the femoral sleeve at the bone to implant interface.Patient had a left distal femoral replacement on (b)(6) 2019 after history of failed hardware plate and screws of the femur.It was revised for loose sleeve component and fracture of the stem sleeve junction.The stem was well fixed with fracture at the threaded portion of the stem, leaving behind the threads of the stem in the sleeve.The sleeve and femoral construct were loose and removed as well was the poly.The tibia was retained as well as the patella component of the left knee.No delay in surgery.Doi:(b)(6) 2019.Dor:(b)(6) 2021.Left knee.
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 150X16MM 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: 12454022
• Report Number: 1818910-2021-19846
• Device Sequence Number: 3515556
• Product Code: JWH
• UDI-Device Identifier: 10603295217992
• UDI-Public: 10603295217992
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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 Model Number: 86-7444
• Device Catalogue Number: 867444
• Device Lot Number: 579554
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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: LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XXSM 12MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 150X16MM FLUTED; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XXSM 12MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 150X16MM FLUTED; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR