MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM DIST STEM TRIAL 17L B; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2576-17-104
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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 client is claiming the present of a black powder inside the s-rom instrument set.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the returned products were examined and it was noted that the anodised colouring on the body was almost all worn off.The products were manufactured in oct 2011 and the cause has been attributed to wear and tear.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Initial medwatch sent with incorrect date in g4.Correcting data in g4.
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: the returned products were examined and it was noted that the anodised colouring on the body was almost all worn off.The products were manufactured in oct 2011 and the cause has been attributed to wear and tear.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.

• Brand Name: SROM DIST STEM TRIAL 17L B
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9785401
• Report Number: 1818910-2020-06750
• Device Sequence Number: 618407
• Product Code: LXH
• UDI-Device Identifier: 10603295146520
• UDI-Public: 10603295146520
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/08/2020

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 Model Number: 2576-17-104
• Device Catalogue Number: 257617104
• Device Lot Number: MT29747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/18/2020; 02/20/2020; 03/24/2020; 03/24/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/05/2020; 03/16/2020; 03/31/2020; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1