MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 70MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a hip revision approximately 19 months post implantation due to the proximal stem segment breaking into two.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 11-300816 ¿ arcos distal stem ¿ 854460, 163670 - cocr head ¿ 64788162, 00631005632 ¿ liner ¿ 64417125, unknown cup ¿ unknown part and lot.Report source: new zealand.The product is in process of being returned to zimmer biomet for the investigaiton.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.H6: component code: mechanical (g04) ¿ stem radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant fit is maintained.There is a proximal femoral implant fracture with varus angulation as noted.No loosening or abnormal radiolucency is identified.There is no radiographic evidence of trauma.Visual examination of the provided pictures identified the stem is discolored and covered in bio-debris.The proximal end of the stem has fractured.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.

• Brand Name: ARCOS CON SZ A HI 70MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15789283
• Report Number: 0001825034-2022-02582
• Device Sequence Number: 14820849
• Product Code: KWA
• UDI-Device Identifier: 00880304474628
• UDI-Public: (01)00880304474628(17)300326(10)845240
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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 Model Number: N/A
• Device Catalogue Number: 11-301331
• Device Lot Number: 845240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Male
• Patient Weight: 90 KG