MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Report source: (b)(6).Concomitant products: trilogy it acetabular system shell p/n 00875304801 l/n 63344546; continuum trilogy it allofit it acebatular system liner p/n 00875200832 l/n 63339363; trilogy it acetabular system shell p/n 00875305001 l/n 63301327.Multiple mdr reports were filed for this event.Please see associated reports: 0001822565-2017-02746, 0001822565-2017-02747, 0001822565-2017-02748, 0001822565-2017-02749.

Event Description

It was reported that during a hip surgery, the liner could not be seated in the shell after implainting the shell.The surgeon removed the shell and replaced it with a bigger one, and the liner still could not be seated it was reported that there was a 60 minute delay.Finally the surgery completed the procedure with a size bigger shell.

Manufacturer Narrative

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.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.As returned, the liners were installed in the shells.The rim of the liners sat flush with the rim of the shells indicating the liners were properly seated.The event reported for liner's not seating in the shells cannot be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
• 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: 6548333
• MDR Text Key: 74547560
• Report Number: 0001822565-2017-02749
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875200932
• Device Lot Number: 63289439
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR