MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 14X115MM CYL DIST; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a left total hip arthroplasty with uncemented competitor implants on an unknown date.In an unknown timeframe postop, the patient fell and experienced a periprosthetic fracture with loosening of the femoral component.The patient underwent revision of the femoral components with implantation of zb components and retention of the initial cup and liner.The fracture was stabilized with fiber tape and cerclage wires, and the procedure was completed without complications.Subsequently, the patient returned for a second revision two years post implantation due to loosening and subsidence of the femoral stem.During the revision, the stem and head were replaced, and the initial cup and liner were retained.
Additional Manufacturer Narrative
(b)(4).D10: 11-301111 arcos brch sz a hi 60mm 174250.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00657.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 and/or corrected information.Updated: g3, g6, h2, h3, h4, h6.Proposed 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 records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided for this revision; however, the per was reviewed by a health care professional.Review of the available records identified the following: the patient had a left tha with uncemented competitor implants on an unknown date.The patient underwent a revision due to periprosthetic fracture and loosening, zb product was placed with competitor product.Another revision was performed for loosening and stem subsidence.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with likely loosening of the femoral stem and possible osteolysis of the greater trochanter as well as subsidence.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint cannot be confirmed, as the mmi report does not definitively confirm loosening or subsidence.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.

• Brand Name: ARCOS 14X115MM CYL DIST
• Common Device Name: PROTHESIS, 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: 18847361
• Report Number: 0001825034-2024-00656
• Device Sequence Number: 20787047
• Product Code: KWA
• UDI-Device Identifier: 00880304473904
• UDI-Public: (01)00880304473904(17)300106(10)691570
• 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: 2022
• 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
• Report Date (Section B): 05/29/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-301414
• Device Lot Number: 691570
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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: Female