MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +75 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source: foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remain implanted.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: 0001822565-2021-00325.

Event Description

It was reported that during a revision procedure the surgeon confirmed that the stem dropped from the tibia component by x-rays during the operation.The operation ended without revision at the surgeon's discretion.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This complaint was confirmed.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 related to the reported event.X-rays were provided and reviewed by a health care professional.Review found a wide gap between the proximal component of the tibial hardware and the tibial stem which have been separated.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.

• Brand Name: STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +75 MM LENGTH
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11282992
• MDR Text Key: 230472300
• Report Number: 0001822565-2021-00326
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00887868249594
• UDI-Public: (01)00887868249594(17)300430(10)64729078
• Combination Product (y/n): N
• PMA/PMN Number: K181947
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 42560007514
• Device Lot Number: 64729078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM 42542006702, LOT 64507513.; ITEM 42542006702, LOT 64507513.