MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SROM 9/10 14X9X125 30; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900526210

Device Problem Difficult to Remove (1528)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 12/19/2017

Event Type  Injury  

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 Description

During the surgery to re-adjustment of the stem anteversion on (b)(6) 2017, it was reported that the taper lock between the stem / sleeve was robust so that it took more than 60 minutes to remove the stem.The surgery was completed by grasping the neck part of the stem with a pliers and pulled it out.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Update: january 25, 2019: the stem component has been provided for examination.Examination of the returned stem finds nothing outward to suggest product error.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy 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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This correction is being submitted to correct the sequential numbering for the follow up report #1.Follow up #2 submitted on 3/23/2018 should have been submitted as follow up #1.Follow up #3 submitted on 9/2/2018 should have been submitted as follow up #2.Follow up #4 submitted on 2/22/2019 should have been submitted as follow up #3 although it appears there are gaps in the sequential follow-up numbers, there are no missing reports.

• Brand Name: SROM 9/10 14X9X125 30
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7198925
• MDR Text Key: 97486917
• Report Number: 1818910-2018-51379
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900526210
• Device Lot Number: 8495911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention