MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problems Incomplete or Missing Packaging (2312); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The complainant 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 that during a total knee arthroplasty, right before the stem was implanted, the poly plug was dropped.It was then found that a screw was missing from it.Cement was pasted between the poly plug and the implant, and the stem was implanted.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The review identified that 24 set screw was consumed.The device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.A definitive root cause cannot be determined.However, during the investigation, we noted that the poly plug was fixated to the tibial plate using bone cement due to a lack of fixation screw.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11348901
• MDR Text Key: 232567529
• Report Number: 3007963827-2021-00035
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K122765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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: 42532006702
• Device Lot Number: 64802997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1