MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER; HIP PROSTHESIS

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the cup disconnected when impacting the implant.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that during hip arthroplasty, the surgeon changed the size of the implant for a larger cup, after the initial, smaller implant construct uncoupled and was unable to be reassembled.The larger size opened for use experienced the same uncoupling; however, this device was able to be reassembled and was used to complete the procedure.The larger size was reported as not suited to the patient's anatomy.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

The device was returned for evaluation.Upon visual examination of device, the liner was detached from the shell.The liner came free during implantation into the acetabulum.The interior and exterior surfaces of the liner were scratched.The inner surface of the shell was scratched / gouged with rim damage that can be seen in the attached photos device history reports and receiving inspection reports were reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.The damage shown in the photos of the returned product suggest that there was an attempt to re-position the shell.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

It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

• Brand Name: ZIMMER MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER
• Type of Device: HIP PROSTHESIS
• 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 46582-0708 ; 5745273773
• MDR Report Key: 5772369
• MDR Text Key: 48855677
• Report Number: 0001822565-2016-02291
• Device Sequence Number: 1
• Product Code: NLF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• 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: 00151504836
• Device Lot Number: 63198073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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
• Patient Age: 64 YR
• Patient Weight: 65