MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 14X9X125 30+4; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900549210

Device Problem Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 11/27/2019

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

The primary surgery was performed on (b)(6) 2016.It was reported that the stem fracture occurred, and the patient visited to the hospital on (b)(6) 2019.The patient was forced to live on crutches because unable to walk due to the stem fracture.Therefore, the revision surgery was performed on (b)(6) 2019 by replacing the head (p/n: 136532120), the stem (p/n: 900549210) with the sleeve (p/n: 550501) via eto.The surgery was completed outside a 30 minutes surgical delay.The surgery time was 218 minutes.General anesthesia, incision was about 23cm.Doctor¿s view: the s-rom stem was slightly varus position, but it was within allowable range.If it breaks, this was a problem with the s-rom stem itself.Possible cause: stem insertion in a slightly varus position.No further information is available.

Manufacturer Narrative

This is a duplicate report of 1818910-2019-124447.1818910-2020-00970 is being retracted as it is a report duplication.1818910-2019-124447 will be kept for investigation purposes.

• Brand Name: SROM 9/10 14X9X125 30+4
• 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: 9560391
• MDR Text Key: 185356273
• Report Number: 1818910-2020-00970
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900549210
• Device Lot Number: 8252270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 60