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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Medical devices: 00801803601, femoral head sterile product do not resterilize 12/14 taper, 63415131; item # unknown, unknown screw, lot # unknown; item # unknown, unknown screw, lot # unknown; item # unknown, unknown screw, lot # unknown; item # unknown, unknown screw, lot # unknown; item # unknown, unknown screw, lot # unknown; 00771100900, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9, 61550152; 121798861, depuy left pinnacle triflange 66 mm custom implant, c76554; 1221-36-058, depuy pinnacle altrx poly acetabular liner, 453317.Report source, consumer - attorney.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00607; 0001822565 - 2018 - 04117; 0001822565 - 2018 - 04118; 0001822565 - 2018 - 04119; 0001822565 - 2018 - 04121; 0001822565 - 2018 - 04122.

Event Description

It was reported that a patient underwent a hip revision surgery due to failure of screw fixation with a competitor custom triflange and dislocation two weeks post implantation.While operating, surgeon noted a large hematoma, grossly loose triflange, and severe bone loss.The hematoma, triflange and liner, head, and screws were removed.For implantation, the surgeon used a cup-cage construct as filler to use for the very large medial wall defect, as well as a new head.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was confirmed with surgical notes.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.No device or photos were received; therefore the condition of the component is unknown.No medical records received.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN SCREW
• 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: 7743286
• MDR Text Key: 115894163
• Report Number: 0001822565-2018-04120
• Device Sequence Number: 1
• Product Code: KWY
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• 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
• Patient Age: 64 YR