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	01/30/2020
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 loosening of the unknown component at cement to implant interface.Unknown cement was used.The femoral products were explanted.Sz 2.5 x 15mm pfc stab poly, two 8 mm posterior augment, two 8 mm distal augment, size 2 femur, 13x90 cemented stem.No lot numbers could be read.Doi: unknown; dor: (b)(6) 2020; right knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null device history batch : null device history review : null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9717133
• Report Number: 1818910-2020-05022
• Device Sequence Number: 3220907
• Product Code: JWH
• UDI-Device Identifier: 10603295217176
• UDI-Public: 10603295217176
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 Model Number: 86-6468
• Device Catalogue Number: 866468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: PFC SIGMA FEM POST AUG SZ2 8MM; PFC SIGMA FEM POST AUG SZ2 8MM; PFC*SIGMA DIS AUG 8MM,SZ2,RGHT; PFC*SIGMA DIS AUG 8MM,SZ2,RGHT; PFC*SIGMA TC3 FEM RT SZ2; SIGMA STAB GVF INS 2 15MM; TAPER CEM STEM 13X90
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR