MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POLY FEMORAL BUSHINGS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Component Missing (2306)

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

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The 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.

Event Description

It was reported the patient underwent a primary oss.The rep was asked to cover the case by a colleague who previously checked the kit and was informed that the missing items in the kit were to follow per surgery.On the day of the surgery, the rep identified the box with the implant that had been sent to re-plan the kit and was placed in to it's respective place in the flight case.The rep visually scanned over the implants as there was no check list for it which may be due to it being an infield movement.The rep did not notice that the femoral bushings were not in the kit and the case was started.The case went on well up until the implants were opened and the surgeon could not find the bushings.The hospital staff and rep searched the kit and the department to find them but were unsuccessful.The colleague who was originally on the case was contacted and stated that the bushings should have been in there, however, there was no indication from theatre care that these were not available.After further searching, a staff member found documentation which had come with previous replenishments.At the bottom of this sheet, there was information stating that the femoral bushings were to follow as quickly as possible.An inquiry by the colleague to theatre care revealed that they were never sent and were sitting in theatre care.The search was abandoned and they continued implantation without the femoral bushes with intention to go back to theater to insert the bushes.The bushings were implanted approximately 7 days later.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.The root cause for the reported issue is attributed to a distribution error.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.

Event Description

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

• Brand Name: OSS POLY FEMORAL BUSHINGS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11785774
• MDR Text Key: 249500541
• Report Number: 0001825034-2021-01390
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150477
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/24/2021
• 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