MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C HI 80MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 650-1068 lot# 3049620 cer option type 1 tpr sleve +6.Cat# 650-1055 lot# 3123214 cer bioloxd option hd 28mm.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00123.The customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised approximately one day post implantation because it was discovered the stem and body were not properly seated in a post-op x-ray.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h3: h6.H6: proposed component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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.

Event Description

No further information is available at the time of this report.

• Brand Name: ARCOS CON SZ C HI 80MM
• Type of Device: PROSTHESIS, 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: 18561995
• MDR Text Key: 333441256
• Report Number: 0001825034-2024-00124
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304474635
• UDI-Public: (01)00880304474635(17)320206(10)250900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301353
• Device Lot Number: 250900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2022
• 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 Sex: Male