MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC* FLUT TIB ROD TRL 115 X 16; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number	866885
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Not Applicable (3189); No Code Available (3191)
Date of Event	08/09/2019
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
It was reported that the tip or end of a sigma universal stem trial was broke off and was stuck in patient's tibia.It was a 16x115 mm stem trial.A surgical dealy of 60-70 minutes.
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).The device associated with this report was not returned 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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Added: b5.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
It was reported that the tip of the trial stem was removed from the patient¿s tibia.

• 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: 8946941
• Report Number: 1818910-2019-102570
• Device Sequence Number: 16654399
• Product Code: LXH
• UDI-Device Identifier: 10603295217671
• UDI-Public: 10603295217671
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,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 Catalogue Number: 866885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 08/15/2019; 09/27/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/02/2019; 09/27/2019
• 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: 55 YR