MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM TM SHELL WITH CLUSTER HOLES; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult To Position (1467); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: biolox delta ceramic femoral head, p/n 00877503601, l/n 2864753; avenir mueller stem, p/n 0106010002, l/n 2870991; liner netural, p/n 00875101036, l/n 63613783.

Event Description

It was reported that after a total hip arthroplasty, radiography revealed the acetabular cup was not fully seated.The patient was reopened, the cup was repositioned, and the acetabular liner, femoral stem and head were removed and replaced.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that after a total hip arthroplasty, radiography revealed the acetabular cup was not fully seated.The patient was reopened, the cup was repositioned, and the acetabular liner, and head were removed and replaced.The shell was not revised.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of surgical notes.Surgical notes shows that the cup was not seated well and this was confirmed through an x-ray.The surgeon removed the liner, impacted the cup again with less anteversion and it was seated well.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 TM SHELL WITH CLUSTER HOLES
• 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: 6757759
• MDR Text Key: 81521572
• Report Number: 0001822565-2017-05213
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00875705201
• Device Lot Number: 63660743
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 77