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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, KK/32; HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, KK/32; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Event Date 09/25/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10 ¿ fitmore, shell with fins, uncemented, 56/kk, item# (b)(6), lot# 3002582.Biolox delta, ceramic femoral head, m¸ 32/0, taper 12/14, item# (b)(6), lot# 3103772.Cls spotorno, stem, 145, uncemented, 6.0, taper 12/14, item# (b)(6), lot# 3048483.G2 ¿ foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00592.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the patient underwent revision surgery on the left hip a year and six days post implantation due to anterior impingement caused by cup positioning.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the patient underwent revision surgery on the right hip a year and six days post implantation due to anterior impingement caused by cup positioning.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, g3, g6, h2, h6.Upon reassessment of the reported event, it was determined to be not reportable as this device is not contributory to the reported event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable as this device is not contributory to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
DURASUL, ALPHA INSERT, HOODED, KK/32
Type of Device
HIP 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 Key17963743
MDR Text Key326005341
Report Number0009613350-2023-00593
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00889024507609
UDI-Public(01)00889024507609(17)230131(10)2937776
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model NumberN/A
Device Catalogue Number01.00013.511
Device Lot Number2937776
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/19/2023
Supplement Dates Manufacturer Received10/04/2023
01/31/2024
Supplement Dates FDA Received10/30/2023
02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2018
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
Patient Weight88 KG
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