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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J ZIMMER MMC CUP

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J ZIMMER MMC CUP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 08/11/2021
Event Type  Injury  
Event Description
It was reported that, legal received the following new claim: patient who presented with severe metallosis after failed hip resurfacing on left with very high cobalt and chromium levels. Decision was made to proceed with left hip revision arthroplasty. No issues reported so far for the right hip. Patient outcome - revision due to metallosis.
 
Manufacturer Narrative
Concomitant medical product: metasul® durom®, component for femur, cemented, 44/j: catalog#: 01. 00211. 144 ; lot#: unknown. 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 report received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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).
 
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Brand NameZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J
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 Key14101529
MDR Text Key289179705
Report Number0009613350-2022-00226
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091003
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 Model NumberN/A
Device Catalogue Number01.00634.052
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
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
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