MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET HV 20G; BONE CEMENT : BONE CEMENT

Catalog Number	3092020
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)
Date of Event	07/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 underwent a left knee revision due to pain, decreased range of motion, swelling, instability, and patella component loosening at the cement to implant and bone to cement interface.The discharge summary noted acute blood loss anemia secondary to the revision.The tibial insert and patella component were the only products revised.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2015, dor: (b)(6) 2016, left 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: device history reviewed 27 sep 19 1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET HV 20G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8950052
• Report Number: 1818910-2019-102649
• Device Sequence Number: 16784831
• Product Code: LOD
• UDI-Device Identifier: 10603295168324
• UDI-Public: 10603295168324
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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 Expiration Date: 11/30/2015
• Device Catalogue Number: 3092020
• Device Lot Number: 7786797
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: 46 YR