MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C STD 60MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat #: 00700007270, lot #: 65550395, 72mm cup size revision shell.Cat #: 00662406525, lot #: 65959931, bone screw self-tapping 25 mm length 6.5 mm dia.Cat #: 00662406550, lot #: 63445353, bone screw self-tapping 50 mm length 6.5 mm dia.Cat #: 00662406520, lot #: 66024209 ,bone screw self-tapping 20 mm length 6.5 mm dia.Cat #: 00662406515, lot #: 65871275, bone screw self-tapping 15 mm length 6.5 mm dia.Cat #: 00625006535, lot #: k241829, bone screw self-tapping 6.5 mm dia.35 mm length.Cat #: 00625006530, lot #: j7488880, bone screw self-tapping 6.5 mm dia.30 mm length.Cat #: p0463058, lot #: 0001641722, avan cmntd shell ss 58mm.Cat #: p0561e58, lot #: 0001683700, avan e1 insert 28 s 58.Cat #: 650-1158, lot #: 3168329, delta cer fem hd 28/0mm t1 unknown ncb plate.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 1 month later due to a greater trochanter fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Mechanical: stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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 or Problem Description
No further information at the time of this report.

• Brand Name: ARCOS CON SZ C STD 60MM
• 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: 19518618
• Report Number: 0001825034-2024-01555
• Device Sequence Number: 6030744
• Product Code: KWA
• UDI-Device Identifier: 00880304474130
• UDI-Public: (01)00880304474130(17)321109(10)273660
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/11/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301303
• Device Lot Number: 273660
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 92 KG