MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 18X13X140 36+8; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900551210

Device Problem Naturally Worn (2988)

Patient Problems Hematoma (1884); Pain (1994); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

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 in (b)(6) 2007 (the date was unknown) via tha at another hospital.It was reported that the patient had a pain and visit the hospital in (b)(6) 2020.The surgeon suspected pseudotumor by x-ray, then, performed the revision surgery on (b)(6) 2020 by replacing the liner, the head and the stem.The tissue and joint fluid were seemed dark.During the surgery, the collected blood overflew from joint.The surgeon confirmed blood tumor, not pseudotumor.The cause of blood tumor was unknown.The surgeon found metal wear of head neck junction.There was no loosening of tissues.The revision surgery was completed successfully, and it was unknown whether there was any surgical delay.No further information is available.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

• Brand Name: SROM 9/10 18X13X140 36+8
• 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: 10302391
• MDR Text Key: 199692107
• Report Number: 1818910-2020-16392
• Device Sequence Number: 1
• Product Code: LWJ
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900551210
• Device Lot Number: 2249537
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS -3; PINNACLE MTL INS NEUT36IDX58OD; 9/10 ULTAMET 36 MM HEADS -3; PINNACLE MTL INS NEUT36IDX58OD
• Patient Outcome(s): Required Intervention