MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER; INSTRUMENT, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00789503602, lot: unk.Part: unk, lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00428, 0001822565-2021-00432.

Event Description

It was reported that the surgeon lost control of the trial heads and three versys head trials were lost inside the patient during surgery and could not be located.The surgeon attempted to find the trials with and without c-arm assistance to no avail.A general surgeon also scrubbed in to try to locate the trials interoperability with no avail.Delay was 30min - 60min.Patient underwent an additional procedure 4 days later and successfully removed all three trial liners.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.An xray was provided and reviewed by a healthcare professional.The review noted there are some semi-spherical radiodensities which project upon the left iliac bone, 1 located at the level of the tip of the acetabular screw and 1 located just superior to this density.Otherwise radiographically grossly unremarkable appearance of left total hip arthroplasty.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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: FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11347834
• MDR Text Key: 232523428
• Report Number: 0001822565-2021-00431
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00789503603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR