MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X190MM SPL TPR DIST; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total hip arthroplasty on an unknown date.Subsequently, the patient was revised due to a periprosthetic fracture.During the procedure, there was issues with the inserter.Attempts were made to fix the proximal body to the distal stem in a ream-over technique.However, it would not work despite the technique being utilized.Multiple attempts were tried to assemble the correct instrumentation to no avail.The surgeon then attempted to fix the proximal body to the distal stem using a bastardised technique to fix the stem and proximal body together.There was a 25-minute delay during surgery due to instrumentation not working.After the case, it was determined that the grey insertion handle was damaged and burred at the insertion end which did not allow the assembly rod to enter.There was no damage noted to the instrument prior to use.It was reported that there was no issue with the stem or proximal body implants.The following day, an x-ray showed that the stem and proximal body had a dubious coupling.It was also noted that the proximal body was hung up on the medial calcar and was not seated in the proximal reamed bone.The surgeon elected to do a revision the next day due to concerns that the construct may fail in the long run, and the stem and proximal body were loose.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: australia.D10: cat# 11-301335 lot# 66623727 arcos con sz e hi 70mm; cat# 31-302001 lot# unknown arcos prox dst stem inserter.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 information.H6: component code: mechanical (g04) - stem.No product was returned for evaluation.However, pictures were provided of the inserter.A visual examination of the provided pictures identified an inserter with cosmetic damage/burrs on the tip.No further evaluation could be made from the provided photos.Review of the device history records for the proximal body/distal stem identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Lot number identification is necessary for review of device history; however, no lot number was provided for the inserter.Radiographs were provided but were not reviewed by a health care professional due to the image being undated; it was unclear whether the pre or post revision was represented.A definitive root cause cannot be determined.The complaint is confirmed based on the photograph of the damaged inserter.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 event information is available at the time of this report.

• Brand Name: ARCOS 18X190MM SPL TPR DIST
• Common Device Name: PROTHESIS, 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: 20516179
• Report Number: 0001825034-2024-02494
• Device Sequence Number: 12514417
• Product Code: KWA
• UDI-Device Identifier: 00880304474284
• UDI-Public: (01)00880304474284(17)321207(10)65688209
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/15/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300918
• Device Lot Number: 65688209
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male