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	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2020
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 cemented femoral stem 13x90mm right side because of fracture.Doi: (b)(6) 2018, dor: (b)(6) 2020.A surgical delay was not reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided photograph and x-ray images confirmed the reported event.The stem was fractured.This device was manufactured on 15-may-2015.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : product code ms866468, lot no.D1505043 manufactured on 15-may-2015.(b)(4) parts were manufactured per specification and all raw materials met specification.No nonconformities were identified.The expire date is 30-apr-2025.Ifu reference no is ifu-0902-00-252.

• 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: 10697068
• Report Number: 1818910-2020-22714
• Device Sequence Number: 19843330
• Product Code: JWH
• UDI-Device Identifier: 10603295217176
• UDI-Public: 10603295217176
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/02/2020

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: 04/30/2025
• Device Model Number: 86-6468
• Device Catalogue Number: 866468
• Device Lot Number: D15050435
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 12MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 29MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X14MM FLUTED; LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 12MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 29MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR