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. CR PROLONG 40MM BRNG +3 RET; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
  • 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. CR PROLONG 40MM BRNG +3 RET; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Catalog Number 110031423
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374)
Event Date 05/30/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01667; 0001822565-2023-01669.D10: item# 110031406; lot# 65255271, item# 110030777; lot# 65054408, item# 113636; lot# 64964393, item# 010000589; lot# 004910.Item# 180551; lot# 162950, item# 180553; lot# 181350, item# 115395; lot# 346240, item# 405800; lot# 495010, item# 406669; lot# 554790, item# 405889; lot# 413380, item# 180556; lot# unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that the patient underwent a revision surgery approximately three (3) weeks ago due to experiencing multiple possible dislocations.Subsequently, during the revision it was noted that the humeral bearing completely disassociated from the humeral tray and visual inspection of the bearing notes damage of the bearing.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned products identified that the humeral bearing was returned with wear and damage.Medical records were not provided.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information is available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CR PROLONG 40MM BRNG +3 RET
Type of Device
SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
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 Key17189675
MDR Text Key317724177
Report Number0001822565-2023-01668
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00887868231544
UDI-Public(01)00887868231544(17)260214(10)64673384
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 11/02/2023
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? Yes
Device Operator Health Professional
Device Catalogue Number110031423
Device Lot Number64673384
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 05/30/2023
Initial Date FDA Received06/23/2023
Supplement Dates Manufacturer Received08/28/2023
10/03/2023
10/31/2023
Supplement Dates FDA Received09/20/2023
10/26/2023
11/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI
Patient Sequence Number1
Treatment
SEE NARRATIVE IN H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
-
-