MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. S-ROM TOTAL HIP SYSTEM-ZTT PROXIMAL SLEEVE

Lot Number 2797552

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 TOTAL HIP SYSTEM-ZTT PROXIMAL SLEEVE
• Type of Device: S-ROM TOTAL HIP SYSTEM-ZTT PROXIMAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. ; warsaw IN
• MDR Report Key: 5187588
• MDR Text Key: 29955472
• Report Number: MW5057536
• Device Sequence Number: 5
• Product Code: KWA
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 2797552
• Other Device ID Number: REF# 55-0524
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61