• 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 UNKNOWN ALLOCLASSIC STEM CEMENTLESS HIP PROSTHESIS

  • 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 UNKNOWN ALLOCLASSIC STEM CEMENTLESS HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930)
Event Date 10/20/2020
Event Type  Injury  
Event Description
It was reported in a journal article that a randomized study comparing metal-on-metal (metasul) and ceramic-on-ceramic (cerasul) bearings was conducted. The present report covers the cerasul group which consisted of 125 thas in a total of 115 patients. At a mean 18-year follow-up, there were six clinical failures in the cerasul group: four ceramic insert fractures (at 6, 13, 14, and 17 years). Revised successfully by one-stage exchange. One late deep infection (at 10 years) which was successfully treated with 2-stage revision. One periprosthetic fracture (at 17 years). No further information is available.
 
Manufacturer Narrative
The described events are part of a study comparing metal-on-metal (metasul) and ceramic-on-ceramic (cerasul) bearings. A prospective, randomized study was originally performed on a consecutive series of 250 cementless primary total hip arthroplasties between 1999 and 2002. For each bearing (metasul or cerasul), 125 that were initially included. They all received a cementless alloclassic® stem (sulzer, switzerland) and allofit® cup (sulzer, switzerland) with a 28-mm head. Only the bearing couples were different, either a mom metasul® (sulzer, switzerland) or a coc cerasul® (sulzer, switzerland) was used. Ceramic head and insert were a third-generation biolox forte® alumina (ceramtec, plochingen, germany). All cases were evaluated both clinically and radiographically, and survival was assessed, considering revisions for aseptic loosening or for any reason as the end points for failure. A randomized study was conducted at 9 years and at a mean 18-year follow-up. The present complaint records the events that are related to the cerasul bearings. Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively. Study results: the cerasul group consisted of 125 thas in a total of 115 patients. At 18-year follow-up, there were six clinical failures in the cerasul group: four ceramic insert fractures (at 6, 13, 14, and 17 years). Revised successfully by one-stage exchange. One late deep infection (at 10 years) which was successfully treated with 2-stage revision. One periprosthetic fracture (at 17 years). Clinical assessment showed radiolucencies around the femoral stems in gruen zones 1 and 7, which is a common occurrence with alloclassic stems. Only 3. 5% of osteolysis in cerasul group were found around the cup in all cases. Because no medical records are available for the reported 6 revisions described in these articles, it was not possible to evaluate the individual reported events in detail. As no lot numbers were provided for the devices, the device history records could not be reviewed. The missing device information has been requested but was not available. At zimmer switzerland manufacturing gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer switzerland manufacturing gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed. Zimmer biomet's reference number of this file is (b)(4). The following reports are associated with this event: 0009613350-2021-00394, 0009613350-2021-00670, 0009613350-2021-00672. References: desmarchelier r, viste a, chouteau j, lerat jl, fessy mh. Metasul vs cerasul bearings: a prospective, randomized study at 9 years. J arthroplasty. 2013 feb;28(2):296-302. Doi: 10. 1016/j. Arth. 2012. 05. 028. Epub 2012 jul 9. Pmid: 22784488. Andeol q, viste a, desmarchelier r, lerat jl, fessy mh. Metasul vs cerasul bearings: a prospective, randomized study at a mean eighteen years. Int orthop. 2020 dec;44(12):2545-2551. Doi: 10. 1007/s00264-020-04855-9. Epub 2020 oct 20. Pmid: 33083903.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN ALLOCLASSIC STEM CEMENTLESS
Type of DeviceHIP PROSTHESIS
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 Key13025348
MDR Text Key282492545
Report Number0009613350-2021-00669
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/17/2021 Patient Sequence Number: 1
-
-