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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - unknown month and day in 2014.Concomitant medical devices: unknown head, unknown stem, unknown cup.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip revision approximately 7 years post implantation due to the liner fracturing into pieces.There was no reported trauma.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Visual examination of the returned product/provided pictures identified the liner had fractured into four pieces.Liner was examined under magnification.Item shows evidence of possible rim fracture.Evidence of scratching and gouges on the outer surface and top of the rim.All 3 of the rim fragments matched together fairly well, indicating little damage occurred after the fracture.Evidence of potential damage from impingement of the femoral component on the rim opposite the fractured pieces leaving apparent flattening of the rim.Possible impingement led to rim damage and/or deformation, further leading to a potential partial levering-out of the head causing edge-overloading on the liner rim opposite, leading to fracture.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: E-POLY 36MM +3 MAXROM LNR SZ23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11748298
• MDR Text Key: 248817037
• Report Number: 0001825034-2021-01271
• Device Sequence Number: 1
• Product Code: MAY
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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: EP-108223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention