MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TC3 BOX TRIAL SZ3; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	201103013
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
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 pain and loosening of the femoral component at the bone to cement interface.Cement manufacturer is unknown.The tibial tray is well fixed, but the femoral component is loose.The surgeon revised the femoral component and retained the well-fixed tibial tray.During the procedure, the hudson adaptor, femoral adaptor rod, and the #3 tc3 box trial broke or were stripped.All the pieces were present.A surgical delay of 1 minute was noted.Doi: (b)(6) 2018.Dor: (b)(6) 2019.Left knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected:h3.Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.Depuy synthes 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: 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: SIG HP REV TC3 BOX TRIAL SZ3
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9162982
• Report Number: 1818910-2019-108038
• Device Sequence Number: 2057329
• Product Code: LXH
• UDI-Device Identifier: 10603295081340
• UDI-Public: 10603295081340
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 201103013
• Device Lot Number: SO2002007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: #4 SIGMA PS LEFT FEMUR; FEMORAL ADAPTOR AND BOLT; FEMORAL AUGMENTS; FEMORAL AUGMENTS; FEMORAL AUGMENTS; FEMORAL AUGMENTS; FEMORAL STEM
• Patient Age: 62 YR