MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 right hip revision approximately four years post implantation due to the stem fracturing just below the head.During the procedure the stem component was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed, no product was provided for evaluation.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 report 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: ECHO POR FMRL LAT NC 12X140MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10194363
• Report Number: 0001825034-2020-02480
• Device Sequence Number: 3408783
• Product Code: KWA
• UDI-Device Identifier: 00880304463400
• UDI-Public: 00880304463400
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 03/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 192112
• Device Lot Number: 293110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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