MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Unequal Limb Length (4534); Swelling/ Edema (4577)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: zimmer cat# 12-115117 cer bioloxd mod hd 32mm +6 nk lot#2971563; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#63688678; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#64653320; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#64908913; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#64908913; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#64208911; zimmer cat#00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length lot#63601785; biomet cat#110010263 g7 osseoti multihole 50mm d lot# 3753111.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02362, 0001825034 - 2021 - 02364.
Event or Problem Description
It was reported the patient underwent revision right total hip arthroplasty approximately 5 months post implantation due to stem subsidence and recurrent dislocation.The surgeon reported significant scarring and was unable to disengage the proximal body from the stem.All devices were removed and replaced except for the cup which remained implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: the patient underwent revision surgery due to stem subsidence and recurrent dislocation.There was a pain using a walker at times.Reports swelling, night pain, and pain with activities.Limited physical exam due to instability and risk for dislocation, notes a history of dislocations.X-rays ¿ healing femoral fracture, subsided modular femoral stem, greater trochanter proximally migrated and radiolucency around the cup.Removed 3 proximal cables as they were loose.Unable to disengage proximal body with slap hammer and 30mm subsidence noted.The fracture site was noted to be healed, 2 new cables were placed.Images not submitted as adequate information is provided in the revision records.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause could not 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 15X150MM SPL TPR DIST
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12302994
• Report Number: 0001825034-2021-02363
• Device Sequence Number: 17095665
• Product Code: MAY
• UDI-Device Identifier: 00880304474178
• UDI-Public: (01)00880304474178(17)270419(10)967600
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/05/2022

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: 11-300815
• Device Lot Number: 967600
• 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: 07/20/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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
• Patient Weight: 57 KG