MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 MAXROM LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet e-poly 40mm +3 maxrom lnr sz24 cat#ep-108424 lot#755220; biomet selex/magnum mod hd 40mm -3 cat#s031140 lot#686950; biomet r/b rloc lhole shl 56mm sz 24 cat#11-106056 lot#342380; biomet ti low profile screw 6.5x25mm cat#103532 lot#678050; biomet tprlc 133 t1 pps so 12x144mm cat#51-103120 lot#3438268.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03388, 0001825034 - 2020 - 03389.

Event Description

It was reported that patient underwent left total hip arthroplasty.Subsequently, patient said it felt different from the beginning than her right hip (which was replaced a few years before left hip).An x ray revealed the liner had failed.Patient underwent revision surgery approximately 5 years post initial implantation.The liner was found cracked and in pieces and there was metallosis.A new locking ring was opened but did not freely move in the ring loc shell.It was determined that the shell should be removed.Cup cutters were used and shell was explanted.A new g7 shell, liner, and ceramic head were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The returned liner has fractured and shows wear on the outside radius of the device.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 40MM +3 MAXROM LNR SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10463746
• MDR Text Key: 204695597
• Report Number: 0001825034-2020-03387
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108424
• Device Lot Number: 755220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• 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