MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 12X190MM SPL TPR DIST; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Joint Dislocation (2374)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a right total hip arthroplasty.Subsequently, the patient was revised approximately 13 years later.During the revision, the surgeon found non-union of the trochanter.The revision was completed without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503204, lot# 2724106 biolox⮠delta, ceramic femoral head, xl, 㸠32/+7, taper 12/14.Cat# 00630504832 lot# 65039055 liner standard 32 mm i.D.For use with 48 mm o.D.Shell.Cat# 00620204822 lot# 07876013 shell porous with cluster holes 48 mm.Cat#47249009700, lot# 65537328 tear drop guide wire 3.0 mm diameter 100 cm length.Cat# 0100101914, lot# 3011183 wagner sl revision⮠hip stem, uncemented, 㸠14/190, taper 12/14.Cat# 00223200206, lot# 56694392 extended 4 hole gtr w/4 cables.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.The patient began experiencing recurrent dislocations that were reduced.A second revision occurred due to instability, non-union, abductor dysfunction, and impingement.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 12X190MM SPL TPR DIST
• 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: 18354764
• Report Number: 0001825034-2023-02966
• Device Sequence Number: 6923852
• Product Code: KWA
• UDI-Device Identifier: 00880304474291
• UDI-Public: (01)00880304474291(17)290206(10)232160
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 11-300912
• Device Lot Number: 232160
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 44 KG