MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ28; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001822565-2021-03702.

Event Description

It was reported the patient underwent a right hip revision approximately 1year post implantation due to dislocation.No additional information.

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: b4, b5, d4, g3, g4, h2, h3, h4, h6.Reported event was confirmed due to the review of medical records.Mmi impressions: right acetabular reconstruction with right total hip arthroplasty.The associated small femoral head is present with possible early loosening of the femoral component.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined, however, it was noted during the investigation that the liner/head combination is not compatible and this combination is considered off-label use.Compatibility can be verified via the compatibility website https://www.Zimmerbiomet.Com/en/support/product-compatibility.Html.It is unknown if this combination caused or contributed to the reported dislocation.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: EPOLY 36MM RLC LNR MROM SZ28
• 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: 13112002
• MDR Text Key: 283401293
• Report Number: 0001825034-2021-03508
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105996
• Device Lot Number: 519460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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#00801803601 FEMORAL HEAD LOT#64210593
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male