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

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER 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 MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Damage to Ligament(s) (1952); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Therapy date : item#:42522401013; articular surface fixed bearing posterior stabilized (ps) right 13 mm height lot#:63133891. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

Bilateral tka performed approximately one year ago. Patient experienced a fall and several weeks later developed right knee pain, swelling, and patella was found to be subluxing/dislocating. Patient underwent revision of right knee patella and poly liner.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALL POLY PATELLA CEMENTED 38 MM DIAMETER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10478427
MDR Text Key205290086
Report Number0002648920-2020-00393
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540000038
Device LOT Number64422815
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/01/2020 Patient Sequence Number: 1
-
-