MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 2 LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1214

Device Problems Corroded (1131); Material Disintegration (1177)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient presented elevated cobalt ion levels and pain.The device failed due to corrosion at the neck-stem junction of the device, corrosion on the oblong taper where the neck was seated in the pocket of the profemur titanium stem, which caused adductor damage, soft tissue reaction and pseudotumor reaction.During the revision the surgeon removed the failed components of the profemur total hip system.

Manufacturer Narrative

Patient and device codes updated.

Manufacturer Narrative

Additional information received on january 28, 2020.Reason for voided: duplicate of incident group: 19020306.

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 2 LONG COBALT CHROME
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9733174
• MDR Text Key: 180552952
• Report Number: 3010536692-2020-00146
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12141
• UDI-Public: M684PHAC12141
• Combination Product (y/n): N
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

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?: No
• Device Operator: Other
• Device Model Number: PHAC1214
• Device Catalogue Number: PHAC1214
• Device Lot Number: 11999427010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/28/2020; 01/28/2020
• Supplement Dates FDA Received: 02/21/2020; 04/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Disability