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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL CLS SPOTORNO, INSERT, 58/28 N/A

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL CLS SPOTORNO, INSERT, 58/28 N/A Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Patient Problems Foreign Body Reaction (1868); Local Reaction (2035); Joint Dislocation (2374); Metal Related Pathology (4530)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative
Medical products: cls cup hip impl win gen; catalog #: unknown; lot #: unknown, cocr head hip impl win gen; catalog #: unknown; lot #: unknown. Therapy date: unknown. The manufacturer received other source documents for review. 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).
 
Event Description
It was reported that the patient was implanted with liner on an unknown side and underwent a revision surgery due to metallosis.
 
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Brand NameMETASUL CLS SPOTORNO, INSERT, 58/28
Type of DeviceN/A
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 Key12432785
MDR Text Key271658317
Report Number0009613350-2021-00473
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
N/A
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 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/15/2002
Device Model NumberN/A
Device Catalogue Number60.13.28-58
Device Lot NumberA835230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/1998
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: 09/07/2021 Patient Sequence Number: 1
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