MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NECK PROVISIONAL R; INSTRUMENT, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: item #:00789503602, provisional head, lot #: unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00690 ,trial head.

Event Description

It was reported during a routing trial head reduction, the trial head came off the trial m/l taper and was lost in the wound.The trial head was located, but it was too deep in the tissues for retrieval to be made.The surgeon finally decided to complete the total hip procedure and leave the trial femoral head in place until procedure to remove could be scheduled for the following day.This caused a 90 minute surgical delay.There is no additional information available.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation identified wear and tear consistent with use over a potential field age of 12 years and 3 months.No further evaluation could be performed with the returned product.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.

• Brand Name: NECK PROVISIONAL R
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9764625
• MDR Text Key: 191075209
• Report Number: 0001822565-2020-00693
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K110836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: 00780502400
• Device Lot Number: 60796174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention