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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED GREEN 12MM; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED GREEN 12MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Naturally Worn (2988); Noise, Audible (3273); Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices - nexgen option femoral component size g right, catalog #: 00599401792, lot #: 63493582, nexgen stemmed precoat tibial component size 5, catalog #: 00598004701, lot #: 63544293, nexgen distal femoral augment block size f 5mm, catalog #: 00599003610 lot #: 63582574, nexgen distal femoral augment block size f 5mm, catalog #: 00599003610 lot #: 63557591, nexgen posterior augment block size f 5mm, catalog #: 00599003601 lot #: 63452087, nexgen straight stem extension 13mm x 100mm, catalog #: 00598801013 lot #: 63566684, nexgen straight stem extension 18mm x 100mm, catalog #: 00598801018 lot #: 63552484.Foreign source: sweden.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.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 right knee arthroplasty revision to address post-operative fracture and migration of the articular surface screw as well as pain, swelling and a clicking noise while walking approximately thirty (30) months post-operatively.Initial operative notes noted no intraoperative complications during implantation.Revision operative notes noted that the migrated screw was found anteriorly and was deformed.The articular surface was loose, but the tibial and femoral components were well-fixed.The patellar component appeared to be damaged locally, however, the rest of the component remained undamaged.Scratches were also identified on the femoral component and metal was found in the synovium, requiring a partial synovectomy.When the surgeon opened a new articular surface, the new screw appeared visually longer than the old one, creating suspicion that the screw had fractured.The surgeon was unable to get good fixation with the new articular surface screw and decided intraoperatively to revise the entire construct.No further intraoperative complications were noted.
 
Manufacturer Narrative
Upon receiving additional information found during investigation of the reported event, it was determined that the event had been previously reported under mdr: 0001822565-2020-00223.All subsequent information/investigation will be processed through the original mdr number.This report should be voided.
 
Event Description
Upon receiving additional information found during investigation of the reported event, it was determined that the event had been previously reported under mdr: 0001822565-2020-00223.All subsequent information/investigation will be processed through the original mdr number.This report should be voided.
 
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Brand Name
NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED GREEN 12MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15447571
MDR Text Key300162961
Report Number0001822565-2022-02680
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00889024225275
UDI-Public(01)00889024225275(17)240731(10)63422524
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K173057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00599404212
Device Lot Number63422524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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