MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHORT CPS PLUG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Study: p.S.Corona, m.Altayo, c.Amat et al., reconstruction of infected post-traumatic bone defects of the distal femur with the compress r implant.Preliminary results of a staged non-biological strategy., injury, https://doi.Org/10.1016/j.Injury.2020.10.016.

Event Description

It was reported via study that one patient was revised due to aseptic loosening of the femoral component.Since the loosening occurred at 4 months after his initial compress surgery, the author attributes the complication to a failure in osseointegration of the implant.No further complications were reported.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

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN SHORT CPS PLUG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11734280
• MDR Text Key: 247594030
• Report Number: 0001825034-2021-01257
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• 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
• Patient Age: 48 YR