MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC HD ARCOM XL 28X44MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 802202801, zb 12/14 cocr hd 28mm x -3.5, 3164624.110024464, g7 dual mobility liner 44mm f, 66227174.110010266, g7 osseoti multihole 56mm f, 66379113.G2: foreign: norway.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the head disengaged from the bearing in the patient post operatively.The surgeon is certain full pressure was added and the head was fully inserted in the bearing.The bearing was still in the liner during the revision surgery.There is no additional information available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with evidence of posterior dislocation and normal position on image three.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays.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 additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d9, g3, g6, h2, h3, h6.Visual examination of the returned product identified there are indentations visible on the od of the device and to both the inner and outer diameter lip of the device.The diameter of the inner hole was checked per the attached print and found in conformance.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause unchanged.This complaint was confirmed based on the provided x-rays.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.

• Brand Name: ACT ARTIC HD ARCOM XL 28X44MM
• Common Device Name: PROSTHESIS, HIPS
• 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: 18959224
• Report Number: 0001825034-2024-00815
• Device Sequence Number: 15793826
• Product Code: LPH
• UDI-Device Identifier: 00880304491359
• UDI-Public: (01)00880304491359(17)280922(10)66202344
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K110555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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,Followup
• Report Date (Section B): 01/10/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: XL-200150
• Device Lot Number: 66202344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 01/06/2025
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/24/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• 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: Unknown