MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device was requested but not returned hospital; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00409.

Event Description

It was reported that the patient underwent a revision procedure approximately 4 years post implantation due to fracture of the poly liner after a dislocation event causing the hip to become unstable.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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: E-POLY 36MM +3 HIWALL LNR SZ23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13618195
• MDR Text Key: 286233809
• Report Number: 0001825034-2022-00408
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304469006
• UDI-Public: (01)00880304469006(17)220317(10)397790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 397790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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
• Treatment: CAT#: 11-363665 COCR HEAD LOT#: 651780
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male