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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH MULLER STEM HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH MULLER STEM HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Ossification (1428); Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Medical products: allofit cup 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 by the (b)(6) register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.
 
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Brand NameMULLER STEM
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 Key11684082
MDR Text Key245979261
Report Number0009613350-2021-00172
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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
Event Location No Information
Date Manufacturer Received09/03/2021
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: 04/19/2021 Patient Sequence Number: 1
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