MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG TIB CEMSTM TRL 13X30 1.5-3; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number	866501
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
During a tka yesterday, the 13x30 cemented stem trial was left in the patient.It was used with a sigma knee.The implant was cemented in place and the wound closed.The retained stem was noted on the x-ray after the patient was out of the or.The doctor has elected to leave the stem trial in the medullary tibial canal.
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.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: SIG TIB CEMSTM TRL 13X30 1.5-3
• Common Device Name: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8358570
• Report Number: 1818910-2019-85403
• Device Sequence Number: 183498
• Product Code: LXH
• UDI-Device Identifier: 10603295217213
• UDI-Public: 10603295217213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 866501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR