MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PIN TRIAL SHELL 58 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701058
Medical Device Problem Codes	Corroded (1131); Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
After surgery within multiple hospital, in 4 orthokits we have found out that the xxx are have oxidated around the incaved letters and numbers when did the device problem occur? after using the orthokits for surgery.Some has rust, some has not.
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 products were returned for investigation.Without further information the cause of the rusting to these products cannot be confirmed and so the complaint will be closed to an undetermined conclusion.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
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.Additional narrative: product complaint # (b)(4).Investigation summary: no products were returned for investigation.Without further information the cause of the rusting to these products cannot be confirmed and so the complaint will be closed to an undetermined conclusion.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: PIN TRIAL SHELL 58 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8873633
• Report Number: 1818910-2019-100459
• Device Sequence Number: 2536693
• Product Code: LXH
• UDI-Device Identifier: 10603295097693
• UDI-Public: 10603295097693
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 07/15/2019

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: 221701058
• Device Lot Number: SO2021453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/11/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/18/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1