• 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. EPOLY 36MM RLC LNR MROM SZ24 PROSTHESIS, 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. EPOLY 36MM RLC LNR MROM SZ24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 07/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 650-1065 cer option type 1 tpr sleve 185000, 15-103204 taperloc micro lat fmrl 10mm 035490, 650-1057 cer bioloxd option hd 36mm 736110, 13-104156 m/h 3hole rlc shl 865730. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03506 head, 0001825034 - 2019 - 03508 cup.
 
Event Description
It was reported that the patient was revised 8 years post-implantation due to dislocation and to correct cup position. Attempts were made to obtain additional information; however, none was available.
 
Manufacturer Narrative
Reported event was confirmed by review of medical records. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined. Medical records/radiographs identified the following: abnormally steep abduction angle (lateral inclination) of the acetabular cup as noted, which may be associated with recurrent dislocations. 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 NameEPOLY 36MM RLC LNR MROM SZ24
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8885968
MDR Text Key154097044
Report Number0001825034-2019-03507
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2016
Device Model NumberN/A
Device Catalogue NumberEP-105994
Device Lot Number280510
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/12/2019 Patient Sequence Number: 1
-
-