Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. CPS LG SPDL WITH PINS 800LBF; COMPRESS ANTI-ROTATION SPINDLES
  • 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. CPS LG SPDL WITH PINS 800LBF; COMPRESS ANTI-ROTATION SPINDLES Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 09/11/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that a patient underwent initial surgery on an unknown date.Subsequently, patient underwent an incision and drainage procedure within 6 months of initial surgery due to a recall of one of the implants for a cleaning issue.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00076.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined this event is not reportable.A review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As reported, an i&d due to infection took place approximately 6 months postoperatively with no devices revised.There are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined this event is not reportable.A review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As reported, an i&d due to infection took place approximately 6 months postoperatively with no devices revised.There are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CPS LG SPDL WITH PINS 800LBF
Type of Device
COMPRESS ANTI-ROTATION SPINDLES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11067187
MDR Text Key223719357
Report Number0001825034-2020-04400
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K101475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number178358
Device Lot Number718580
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received01/08/2021
05/11/2021
Supplement Dates FDA Received01/28/2021
05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
BIOMET CPS LG SPDL WITH PINS CAT#178358 LOT#817690
Patient Outcome(s) Other;
-
-