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

MAUDE Adverse Event Report: ZIMMER, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE SEMI CONSTRAINED

  • 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, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE SEMI CONSTRAINED Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative

(b)(6). This report is number 2 of 4 mdrs filed for the same patient (reference 0001822565-2017-04518 / 0001822565-2017-04520 / 0001822565-2017-04521). Concomitant devices ¿ zimmer talar component orange size 4 right, catalog # 00450002400, lot # 77003947; zimmer prolong tibial insert sz 4 +0, catalog # 00450005400, lot # 62579583; zimmer distal lateral fibular plate right 6 holes 106 mm length, catalog # 00235701706, lot number #unknown; zimmer palacos cement, catalog #: ni, lot #: ni. The complaint device is not expected for return currently, as it remains implanted, but a supplemental medwatch 3500a will be submitted upon receipt of additional information. The investigation is in process.

 
Event Description

It was reported that patient underwent a right ankle procedure. Subsequently, the patient experienced mild swelling, mild stiffness, mild tenderness, mild weakness, mobility issues, some issues with performing usual daily activities, and moderate pain or discomfort noted at six (6) week post-operative follow-up. At the six (6) month post-operative follow-up, mild swelling, mild stiffness, mild to moderate pain or discomfort, and some range of motion restrictions were noted, however it also noted the ankle was better and the patient was satisfied. At the one (1) year post-operative follow-up, mild swelling, mild stiffness, and some problems with performing usual daily activities, moderate pain or discomfort, and some range of motion restrictions. At the two (2) year post-operative follow-up, mild swelling, mild stiffness, some problems with walking, moderate pain or discomfort, and some range of motion restrictions were noted. Additionally, osteolysis was noted on radiograph findings. The patient continues to report that they are satisfied and that the ankle is improving. No further treatment has been indicated at this time.

 
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 history record was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. 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.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTALAR COMPONENT ORANGE SIZE 4 RIGHT
Type of DevicePROSTHESIS, ANKLE SEMI CONSTRAINED
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6678402
MDR Text Key78765977
Report Number0001822565-2017-04519
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00450002400
Device LOT Number77003947
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/14/2014
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: 06/29/2017 Patient Sequence Number: 1
-
-