MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIDE EXP DSTL FMRL RT 21CM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned because it 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 the patient underwent a knee arthroplasty.Subsequently, the device was noted to have regressed during x-ray follow-up which cause the patient leg length discrepancy.The device will not be removed as it is able to lengthen properly.However, the surgeon is having to make up for the length loss with additional lengthening in a faster time frame.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.H3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was further reported the expandable device was removed.However, the reason for revision was not due to the reported malfunction.

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.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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: SIDE EXP DSTL FMRL RT 21CM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10179308
• MDR Text Key: 195987047
• Report Number: 0001825034-2020-02357
• Device Sequence Number: 1
• Product Code: JWH
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP114748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 09/28/2020
• Supplement Dates FDA Received: 09/03/2020; 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR