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

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); 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 ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign source: china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the implant was not assembling with mating implant.Attempts to obtain additional information have been made; however, no more is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
 
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.Visual evaluation of the returned device shows an articular surface with no evidence of implantation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
Type of Device
PROSTHESIS KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI 
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI  
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15604960
MDR Text Key301737540
Report Number3007963827-2022-00257
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00889024641365
UDI-Public(01)00889024641365(17)281011(10)64821995
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K113369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42511400712
Device Lot Number64821995
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/20/2022
Initial Date FDA Received10/14/2022
Supplement Dates Manufacturer Received10/14/2022
12/30/2022
Supplement Dates FDA Received11/02/2022
01/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2020
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
Patient Age2 YR
Patient SexFemale
-
-