MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXERA CUP 40MM X 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 0106010003, avenirâ® mã¼ller, stem, standard, uncemented, ha, 3, taper 12/14, 2942684 00-8775-040-01, biolox delta hd 12/14 40x-3.5, 2948866.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's hip was revised due to acetabulum tipping.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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: MAXERA CUP 40MM X 50MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8368387
• MDR Text Key: 137113821
• Report Number: 0001822565-2019-00837
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: EXPORT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• 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: 00151505040
• Device Lot Number: 64014064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• 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