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. LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS; PROSTHETIC, HIP
  • 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. LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2023
Event Type  malfunction  
Event Description
It was reported that the shipment was received with a hair in the box.There was no patient involvement reported.There is no additional information available at the time of this report.
 
Manufacturer Narrative
(b)(4).G2: foreign: thailand.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The debris were found on the outside of the packaging therefore sterility was no compromised.The initial report was forwarded in error.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The debris were found on the outside of the packaging therefore sterility was no compromised.The initial report was forwarded in error.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS
Type of Device
PROSTHETIC, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key17739743
MDR Text Key323323778
Report Number0001822565-2023-02493
Device Sequence Number1
Product Code KWY
UDI-Device Identifier00889024633216
UDI-Public(01)00889024633216(17)271228(10)65745156
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/20/2023
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 Number00500104222
Device Lot Number65745156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/21/2023
Initial Date FDA Received09/13/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received11/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
-
-