MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN RECAP FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Collapse (1099); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: unknown, unknown m2a magnum acetabular component, unknown.- report source, literature: gaillard, e.B., gaillard, m.D., gross, t.P.(2017).Interventions for improving hip resurfacing outcomes in women: a high-volume, retrospective study.The journal of arthroplasty, 32(11), 3404-3411.Doi: 10.1016/j.Arth.2017.06.003.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 in a journal article that the patients were revised following hip resurfacing arthroplasty.Thirteen patients were revised due to femoral fracture/head collapse.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this report is a duplicate of a previously submitted medwatch form.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN RECAP FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7431615
• MDR Text Key: 105513171
• Report Number: 0001825034-2018-02730
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/14/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/04/2018
• 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