MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TAPER CEM STEM 13X90; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	866468
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Patient reported with painful and unstable revision knee construct (tc3 fb with cemented stem).Radiograph showed apparent broken tibial stem extension at the stem/tray interface.Revised fb tray and 13x90 cemented stem to a 25mm rp build-up tibial tray and 13x90 cemented stem with a 10mm tc3 rp poly resulting in a stable construct.Patient experienced post-op device malfunction.Tibial stem extension sheared off at the stem extension tibial tray interface,.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Review of the provided x-ray could not confirm the reported fracture, but further review of the received photographs can confirm implant fracture.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.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8413265
• Report Number: 1818910-2019-87047
• Device Sequence Number: 13512866
• Product Code: JWH
• UDI-Device Identifier: 10603295217176
• UDI-Public: 10603295217176
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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 Catalogue Number: 866468
• Device Lot Number: D13110024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR