MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY RLC 32MM 10DEG SZ23; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported patient underwent a hip revision approximately 6 years post implantation due to the implant broken on the rim.No additional information.
Event or Problem Description
It was reported the patient underwent a primary right tha.Subsequently was revised for a liner fracture.Surgeon reported locking ring was found in fixed position, as well as staining and metal debris, revised shell, liner, head and retained femoral stem.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, b4, b5, g4, h2, h3, h6.Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection the scallops on one side of the liner had fractured.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: EPOLY RLC 32MM 10DEG SZ23
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10385048
• Report Number: 0001825034-2020-03079
• Device Sequence Number: 3446847
• Product Code: JDI
• UDI-Device Identifier: 00880304451513
• UDI-Public: (01)00880304451513(17)200626(10)520060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 06/26/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105833
• Device Lot Number: 520060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 11/10/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/24/2020; 11/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ACETABULAR SHELL.; UNKNOWN FEMORAL HEAD.; UNKNOWN FEMORAL STEM.; UNKNOWN ACETABULAR SHELL; UNKNOWN FEMORAL HEAD; UNKNOWN FEMORAL STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention