MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X200MM INTLKNG DIST; PROTHESIS, HIPS

Model Number N/A

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 11-301321 arcos con sz a std 70mm 626650 166066 arcos distal screw ti 5x30mm m 7032012 166067 arcos distal screw ti 5x35mm m 6973109 g2: foreign: australia multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 -00525 0001825034 - 2024 -00528 0001825034 - 2024 -00529 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.

Event Description

It was reported the patient had an initial total left hip arthroplasty performed on an unknown date with unknown implants.Subsequently, the patient was revised due to femoral periprosthetic fracture associated with loosening stem.The patient was implanted with zimmer biomet devices during the revision surgery and was revised for a second time three years post implantation for implant subsidence.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6.Two images of the explanted stem were supplied with the x-rays; the image shows the cone body separated from the stem.The photos also show the ceramic head, but no information about the head can be obtained from the image.A review of the device history records identified no related deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: left hip arthroplasty with subsidence of the femoral implant and suspected retraction of the distal femoral screws.A definitive root cause cannot be determined; however, it was noted that a depuy liner was used with zimmer biomet hip components, and this is considered off-label use as ¿the system is used with biomet type 1 taper modular heads and compatible biomet acetabular shells/liners and screws¿, it is unknown if this off label use caused or contributed to the reported event.Event is confirmed via medical records.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: ARCOS 15X200MM INTLKNG DIST
• Type of Device: 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: 18779346
• MDR Text Key: 336233719
• Report Number: 0001825034-2024-00526
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-301815
• Device Lot Number: 358810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG