MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown if the liner was replaced in first revision.Concomitant medical products: 010001033 ¿ cocr head ¿ 6411879.11-301416 ¿ arcos distal stem ¿ 348660.11-301113 ¿ arcos cone ¿ 301113.Unknown cup ¿ unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product was not returned by the patient.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 - 2020 - 03179.

Event Description

It was reported that patient underwent a second right hip revision approximately 3 months post first revision due to pain and dislocation.The head, liner and stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d6; g4; h2; h3; h6.Reportable event was unable to be confirmed due to limited information provided by the customer.X-rays reviewed by a third party hcp notes right total hip arthroplasty with placement of a lateral femoral plate and cerclage wire fixation device for what appears to be fractures involving the greater and lesser trochanter.There are due to the previous fracture and not related to this event.The dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: E-POLY LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10405413
• MDR Text Key: 202878911
• Report Number: 0001825034-2020-03180
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304468962
• UDI-Public: (01)00880304468962
• Combination Product (y/n): N
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 499060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• 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
• Patient Weight: 102