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

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-00177, 01555, 01556.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a second revision due to dislocation.During the procedure, it was revealed that the acetabular construct had loosened and the femoral stem was retroverted.The stem retroversion was noted to have contributed to the recurrent dislocation.All components were removed and replaced.Attempts to obtain additional information have been made; however, no further information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN CUP
• 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: 6389157
• MDR Text Key: 69437858
• Report Number: 0001822565-2017-01558
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• 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