MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN SELF-TAP BONE SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620205020 63379131 shell porous 54 mm with multi holes.00631005032 63569815 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells.00801803203 63375195 femoral head sterile product do not resterilize 12/14 taper.00998201718 61699332 femoral stem - revision taper - nitrided cementless 17 mm diameter 185 mm stem length.(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04026.

Event Description

It was reported that during surgery, the surgeon was inserting screw to secure the cup.The screw went through the cup and into the acetabulum.The screw remains in patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under (b)(4).

• Brand Name: UNKNOWN SELF-TAP BONE SCREW
• 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: 6637532
• MDR Text Key: 77453403
• Report Number: 0001822565-2017-04025
• Device Sequence Number: 1
• Product Code: JDG
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/12/2017
• 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): Other