MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B STD 70MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown arcos distal stem, unknown femoral head.Foreign country: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure for unknown reason.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported patient underwent a revision procedure due to infection.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The reported event of deep infection >90 days occurred post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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.

Event Description

It was reported patient underwent initial hip arthroplasty on unknown date.Subsequently; the patient was revised due to unknown reason.The patient was later revised for a second time approximately ten months post revision due to infection.Additional information on the reported event is unavailable.

• Brand Name: ARCOS CON SZ B STD 70MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11057114
• MDR Text Key: 223189286
• Report Number: 0001825034-2020-04408
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301322
• Device Lot Number: 013250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 02/11/2021
• Supplement Dates FDA Received: 01/13/2021; 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention