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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC CUP, UNCEMENTED, 56 MM/48 MM, CODE N

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC CUP, UNCEMENTED, 56 MM/48 MM, CODE N Back to Search Results
Model Number N/A
Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. Medical products: metasul ldh head adapter, m, 0, taper 12/14-18/20; catalog#: 01. 00185. 146; lot#: 2585758. Metasul ldh head, 48, code n, taper 18/20; catalog#: 01. 00181. 480; lot#: 2543942. Fitmore hip stem, uncemented, b/7, taper 12/14; catalog#: 01. 00551. 207; lot#: 2538809. Therapy date: (b)(6) 2021. The manufacturer did not receive x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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
Patient was implanted on the unknown side and underwent revision surgery due to osteolysis, metallosis (trunnionosis).
 
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Brand NameZIMMER MMC CUP, UNCEMENTED, 56 MM/48 MM, CODE N
Type of DeviceZIMMER MMC CUP
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 Key11617887
MDR Text Key246380615
Report Number0009613350-2021-00160
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K091003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberN/A
Device Catalogue Number01.00634.056
Device Lot Number2528553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2009
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: 04/06/2021 Patient Sequence Number: 1
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