MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. S-ROM METAL ON METAL FEMORAL HEAD

Lot Number 2910709

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Toxicity (2333); Reaction (2414); Test Result (2695)

Event Type  Injury  

Event Description

Pinnacle metal-on-metal hip implant was implanted (b)(6) 2009, with some pain since then.Revision was done (b)(6) 2015, with findings of metallosis, fluid and metal stained tissue in the joint.Elevated blood metal ion levels.

• Brand Name: S-ROM METAL ON METAL FEMORAL HEAD
• Type of Device: S-ROM METAL ON METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. ; warsaw IN
• MDR Report Key: 5187588
• MDR Text Key: 29955472
• Report Number: MW5057536
• Device Sequence Number: 4
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2015
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 2910709
• Other Device ID Number: REF# 1365-31-000
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61