MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 12X7X115 30; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900524210

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  malfunction  

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 Description

The primary surgery was performed via tha (date of surgery was unknown).It was reported that the revision surgery was scheduled to be performed on the patient¿s right hip joint by replacing the s-rom stem (p/n: unknown) and not replacing the sleeve due to pain, stem breakage (date of surgery was not fixed yet).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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 was received.Root cause undetermined.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: was manufactured on 19/september/2016.(b)(4) parts were manufactured per specification and all raw materials met specification.There were no ncs associated with this lo.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.

• Brand Name: SROM 9/10 12X7X115 30
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9413191
• MDR Text Key: 184435103
• Report Number: 1818910-2019-120408
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Report Date: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900524210
• Device Lot Number: 8388874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: S-ROM SLEEVE