MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RS SIDE EXP DSTL FMRL LT 15CM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: (b)(6) 2020, 150478 oss poly lock pin 104760, 150493 oss reinforced yoke 888420, 888420 oss rs axle 552090, 161034 oss rs poly fem bushings set/2 155730, 150476 oss poly tibial bushing 850230, 161040 oss rs non-mod plt shrt 71 826540, 178512 cps nut co-cr-mo alloy 484110, 178538 cps centering sleeve 16mm 548010, 178351 cps xs spdl with pins 600lbf 498540, 178526 cps transverse pin 6pk 28mm 787280, 178404 cps anchor plug 14mm 332040, 161095 oss rs 14mm ls tibial bearing 729400.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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 total right oss knee arthroplasty.Approximately 22 months post implantation, there was difficulty during the lengthening process of the oss femur, in which the femur could not be expanded.There has been no revision reported to date.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RS SIDE EXP DSTL FMRL LT 15CM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9717732
• MDR Text Key: 206097918
• Report Number: 0001825034-2020-00745
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: N/A
• Device Catalogue Number: CP114831
• Device Lot Number: 252430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 15 YR