MAUDE Adverse Event Report: ZIMMER, INC. UNK FEMORAL HEAD; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Compatibility Problem (2960)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion to the cause of the event.Lee, soong joon et al (2016)."bearing change to metal-on-polyethylene for ceramic bearing fracture in total hip arthroplasty; does it work?" the journal of arthroplasty, 31, 204-208.Http://dx.Doi.Org/10.1016/j.Arth.2015.08.039.

Event Description

A patient identified in the article underwent hip revision due to metallosis and elevated metal ion levels.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNK FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6420500
• MDR Text Key: 70446569
• Report Number: 0001822565-2017-01820
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR