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

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

  • 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 SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12. 5 extended offset catalog#: 00771101220; unknown; lot#: 60746864, metasul® ldh®, head, 46, code l, taper 18/20 catalog#: 0100181460; lot#: 2397377, metasul® ldh®, head adapter, s, -4, taper 12/14-18/20 catalog#: 01. 00185. 145; lot#: 2414462. Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer. Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department. As soon as supplemental information becomes available an updated report will be submitted. The manufacturer did not receive x-rays, or other source documents for review. Surgical reports were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was reported that failed left total hip replacement. Revision surgery. Left hip degenerative arthritis. Left tha. An aggressive synovectomy is necessary to dislocate the hip. The tissue had a brownish discoloration. With just a quarter turn pass, the cup was found to be grossly loose. There was no evidence of bony ingrowth.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUROM US ACET CMPNT 52/46 L
Type of DeviceDUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key14101562
MDR Text Key289176650
Report Number0009613350-2022-00228
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/15/2012
Device Model NumberN/A
Device Catalogue Number01.00214.152
Device Lot Number2395162
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
-
-