MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 50MM TRL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03347.

Event Description

It was reported during a revision of an unknown product that a 50 mm high offset arcos cone proximal trial was inserted on a 20 mm sts distal stem for trialing.The trial would not disengage from the stem.The surgeon decided to use the 21 mm sts distal stem.No adverse events have been reported as a result of the malfunction.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.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

The visual inspection found the surface of the cone body trial to be scratched, discolored and dinged consistent with a multiple-use instrument.Scraping on the underside of the cone body corresponds to the same location as the damage was found on the stem.The cone body bolt is engaged with the threads of the stem's taper.The bolt rotates freely inside the threads.Attempts were made to dislodge the stem and cone body, however, we were not able to separate the trial from the stem.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event for the trial.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 event information available at the time of this report.

• Brand Name: ARCOS CON SZ A HI 50MM TRL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10457915
• MDR Text Key: 205715138
• Report Number: 0001825034-2020-03348
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-301310
• Device Lot Number: 473382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 10/23/2020
• Supplement Dates FDA Received: 09/17/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET TPR DIST CAT#11-301020 LOT#462790