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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH MS-30, STEM, STANDARD, CEMENTED, 8, TAPER 12/14 MS-30 FEMORAL STEM STANDARD AND LATERAL

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ZIMMER SWITZERLAND MANUFACTURING GMBH MS-30, STEM, STANDARD, CEMENTED, 8, TAPER 12/14 MS-30 FEMORAL STEM STANDARD AND LATERAL Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: bone screw self-tapping 6. 5 mm dia. 30 mm length, catalog #: 00625006530; lot #: 62292642, constrained liner with constraining ring 36 mm i. D. Size mm for use with 60 mm o. D. Size mm shell, catalog #: 00875801436; lot #: 63097134. Therapy date: (b)(6) 2020. The manufacturer received other source documents for review. 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 an unknown side and underwent revision surgery due to squeaking noise and instability.

 
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Brand NameMS-30, STEM, STANDARD, CEMENTED, 8, TAPER 12/14
Type of DeviceMS-30 FEMORAL STEM STANDARD AND LATERAL
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 Key10413335
MDR Text Key203120816
Report Number0009613350-2020-00380
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK040803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number30.00.49-080
Device LOT Number2915186
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/17/2020 Patient Sequence Number: 1
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