MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RS SIDE EXP DSTL FMRL RT 18CM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

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 patient has the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial knee arthroplasty and approximately three years after the procedure, it was prolonged for 2,5 cm.One month ago, it collapsed to the first position, failure of the expandable and patient was revised to a regular segmental rs femur system.It occurred in normal use.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Photographs and radiographs were provided, however the complaint cannot be confirmed.Visual examination of the provided pictures identified some light scratch marks on the device and it was not expanded.Review of the radiographs identified the following: there are no dates on the images provided and no dl stating the date taken.As there are no dates on image, and no images for comparison to assess the event reported, images being submitted for review to mmi would not enhance the investigation at this time.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: RS SIDE EXP DSTL FMRL RT 18CM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10453860
• MDR Text Key: 204364737
• Report Number: 0001825034-2020-03305
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140509
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: N/A
• Device Catalogue Number: CP114845
• Device Lot Number: 525130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• 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: 16 YR
• Patient Weight: 49