• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE B 12 MM HEIGHT PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE B 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Damage to Ligament(s) (1952)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-00668. Concomitant medical devices: seg dist fem size b rt item# 00585004202 lot# 64073213; stem extension straight 12mm dia x 100mm length(combined length 145mm) item# 00598801012 lot# 64080937; polyethylene insert xt size b use with distal femoral xt size b use with xt only item# 00585001296 lot# 64036066; segment with male/female taper 30 mm length item# 00585004603 lot# 64036552; fluted stem extension straight precoat 14 mm diameter 130 mm length item# 00585205014 lot# 63793365; tibial component precoat size 5 item# 00588000500 lot# 63753875; all poly patella standard size 38 mm diameter 9. 5 mm thickness cemented item# 00597206538 lot# 63289114; stem collar 35 mm o. D. For use with 16 mm or smaller diameter segmental stems item# 00585204035 lot# 63720636. Report source: (b)(6). Customer has indicated that 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 a patient was revised approximately one year and three months post implantation due to ligament laxity. The patient had complained in clinic of his knee ¿not feeling right¿, so an evaluation was carried out under c-arm visualization. At this investigation it appeared to the surgeon that there was significant opening at the joint line, and so it was assumed that the femoral hinge axle had broken. The patient is a robust (strong, not obese) male, (b)(6), and the surgeons guessed that he may have over-stressed the implant beyond what would be normal for a salvage prosthesis. At the revision surgery, while the patient was under anesthetic, the surgeon again assessed joint laxity and confirmed that revision was necessary for the reason anticipated above. However, upon accessing the joint we noted that there was no sign of metallosis which would reasonably be expected in the presence of a fractured implant. The hinge locking cap was removed, and the axle was withdrawn intact, straight, and not broken! all other visible parts of the construct were examined closely and were likewise shown to be intact and in relatively pristine condition. Therefore, the decision was made to disengage, remove and exchange the femoral component and exchange the articular surface.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE B 12 MM HEIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9811391
MDR Text Key191860528
Report Number0001822565-2020-00881
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00585002012
Device Lot Number63953180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2018
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 Treatment Data
Date Received: 03/10/2020 Patient Sequence Number: 1
-
-