MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Material Fragmentation (1261)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Device product code - ni.Expiration date - ni.Device code - 2616 malposition of device.Manufacture date ¿ ni.

Event Description

Legal counsel for patient reported that the patient's left hip was revised two years post-implantation due to fragmentation and failure of polyethylene, fractured locking ring, evidence of a dome screw wear on the backside of the liner, metallosis stained synovial tissue in the periacetabular region and malposition of the dome screw.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under mfr number 1822565.

• Brand Name: UNKNOWN HIP
• Type of Device: PROSTHESIS, HIP
• 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: 6309472
• MDR Text Key: 66763072
• Report Number: 0001822565-2017-00531
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• 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: 60 YR