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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 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: 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
• 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: 18779346
• Report Number: 0001825034-2024-00526
• Device Sequence Number: 4342700
• Product Code: KWA
• UDI-Device Identifier: 00880304475144
• UDI-Public: (01)00880304475144(17)310125(10)358810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/14/2024

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: 11-301815
• Device Lot Number: 358810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG