MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL LONG FLANGE CAGE, LEFT USE WITH 62/64MM SHELLS/54MM LINERS; TEMPLATE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 10/04/2017

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.Concomitant medical products: 00801802230, femoral head sterile product do not resterilize 12/14 taper, 63341119; 00662406550, bone screw self-tapping 50 mm length 6.5 mm dia., 62825586; 00662406520, bone screw self-tapping 20 mm length 6.5 mm dia., 63204307; 00662406535, bone screw self-tapping 35 mm length 6.5 mm dia., 63103850; 00771100900, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset, 61550152; 00700006220, trabecular metalâ¿¢ acetabular revision shell, 63232024; 2080-0020, stryker screw restoration plate, 5y32vx; 2080-0020, stryker screw restoration plate, r36hr3; 2080-0030, stryker screw restoration plate, 1d61ky; 2080-0015, stryker restoration gap plate screw, wx4116; 6197-9-001, stryker cement simplex antibiotic bone, mbx012; 2080-0035, stryker screw restoration plate, 1v7at4; 690-00-22d, stryker acetabular liner, j41rpp; 500-01-48d, stryker acetabular shell, 50483701; 1236-2-244, stryker mdm x3 insert, 321909; 2082-0052l, stryker acetabular shell, unknown lot number.Report source, consumer - attorney.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00615, 0002648920 - 2018 - 00616, 0002648920 - 2018 - 00617, 0002648920 - 2018 - 00618.

Event Description

It was reported that a patient underwent a hip revision surgery due acetabular fracture and loosening, dislocation, stiff hip, broken plate and screw, loose cage approximately 11 months post implantation.The patient has been reported to have severe bone loss and the increase in surgeries has contributed to failures.There were broken screws that were retained in the ilium from the broken ear off the cage and bone fracture, but the screws were removed.A new revision shell was selected along with a new cage, liner, head, and screws.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: PROVISIONAL LONG FLANGE CAGE, LEFT USE WITH 62/64MM SHELLS/54MM LINERS
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7743292
• MDR Text Key: 115823277
• Report Number: 0001822565-2018-04145
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00713606254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR