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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10405413
• Report Number: 0001825034-2020-03180
• Device Sequence Number: 2942767
• Product Code: MAY
• UDI-Device Identifier: 00880304468962
• UDI-Public: (01)00880304468962
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K090103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 102