MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 20X190MM SPL TPR DIST HA; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Concomitant medical products: 22-301324, arcos con sz d std 70mm ha, 861510, 22-300920, arcos 20x190mm spl tpr dist ha, 821720.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 that disassembly tools would not disengage the cone body from the stem.The surgeon could not remove the arcos and had to stitch the patient up causing a delay of more than 30 minutes.No additional information provided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Udi : (b)(4).Concomitant medical products : 22-301324, arcos con sz d std 70mm ha, 861510.Pma/510k : devices is not cleared for distribution in us; however, a similar device is cleared under k090757.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04728.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that during a revision due to infection the arcos modular stem was not able to be removed.The screw was removed with disassembly tool, however the cone body won't disengage from the distal stem.The stem won't come out even after the surgeon tried with slap hammer with the cone body and distal stem.The patient was sutured back and sent to another hospital.No additional information was made available.

• Brand Name: ARCOS 20X190MM SPL TPR DIST HA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7656081
• MDR Text Key: 112991444
• Report Number: 0001825034-2018-04216
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 22-300920
• Device Lot Number: 821720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization