MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS PROXIMAL REAMER SIZE B; INSTRUMENT, HIP

Model Number N/A

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2024

Event Type  Injury  

Event Description

It was reported that the size b proximal reamer had bone debris fall out from inside the reamer into the patient's open hip during the operation.The reamer reportedly hadn't been cleaned or sterilized properly from when it was used previously, and the debris was another patient's bone.It was reported that currently, the patient does not have an infection.There were no contributing factors other than the reamer not being cleaned properly.There was a slight delay in surgery while the hip was cleaned and washed out.Surgical technique was used correctly.No additional information was received.

Manufacturer Narrative

(b)(4).G2: foreign country: australia customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: UNKNOWN ARCOS PROXIMAL REAMER SIZE B
• Type of Device: INSTRUMENT, 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: 19144452
• MDR Text Key: 340608958
• Report Number: 0001825034-2024-01055
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• 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: 04/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male