MAUDE Adverse Event Report: ZIMMER DRESS-FIT PLASMA SPRAYED; FEMORAL STEMS

Catalog Number 7711-12-40

Device Problems Corroded (1131); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Toxicity (2333); Osteolysis (2377); Test Result (2695)

Event Type  Injury  

Event Description

This report contains 15 zimmer femoral stems implanted in patients who had a contemporary metal-on-polyethylene total hip replacement and were / are diagnosed with mechanically assisted crevice corrosion, defined here as having new onset otherwise unexplained pain and elevated serum cobalt levels of 1.6mg/ml or greater.At this time 9/15 (60%) have been revised (component removed), all patients revised had visible corrosion at the head neck junction with soft tissue pathology of varying degrees.In a single surgeon database macc prevalence was 1.1% in a consecutive series of contemporary zimmer non-cemented femoral hip components.Mechanically assisted crevice corrosion (macc) occurs at the metal / metal modular junctions in total hip replacements and can lead to adverse local tissue reaction in patients with metal-on-polyethylene total hip replacement.In summary, a single surgeon evaluated his database and determined a macc prevalence of 1.1% in a consecutive series of contemporary zimmer non-cemented femoral hip components followed for a minimum of 2 years.This clinical complication is worrisome because of both the high volume of hip replacement worldwide and the soft tissue damge that can occur with severe reactions.Also see mw5039866 - mw5039880.

• Brand Name: DRESS-FIT PLASMA SPRAYED
• Type of Device: FEMORAL STEMS
• Manufacturer (Section D): ZIMMER; warsaw IN
• MDR Report Key: 4379839
• MDR Text Key: 5289761
• Report Number: MW5039874
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 7711-12-40
• Device Lot Number: 60716081
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention