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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/140; HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/140; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 06/05/2023
Event Type  Injury  
Event Description
It was reported that patient underwent right hip revision due to stem fracture which occurred while out walking about five (5) years after the initial surgery.No additional information or outcomes have been provided.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).D10 - avan reld acet shl ss ha 58mm, item# p0460p58, lot# 0001224269; avan uhmwpe insert 58/28, item# p0561058, lot# 0001300407; revitanâ®, proximal part, cylindrical, uncemented, 55, taper 12/14, item# 01.00402.055, lot# 947827; protasulâ®, s30 head, s, 㸠28/- 4, taper 12/14, item# 302805, lot# 2957272.G2 ¿ foreign ¿ germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
Upon reassessment of the reported event, it was determined that medwatch report should not have been filed due to complaint being duplicate of (b)(4) _medwatch # mdr339140.Report id: 0009613350-2023-00266.Given this information, this medwatch will be voided.
 
Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined that medwatch report should not have been filed due to complaint being duplicate of (b)(4) medwatch # mdr339140.Report id: (b)(4).Given this information, this medwatch will be voided.
 
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Brand Name
REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/140
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 Key17622867
MDR Text Key321932917
Report Number0009613350-2023-00493
Device Sequence Number1
Product Code MRA
UDI-Device Identifier00889024592940
UDI-Public(01)00889024592940(17)230531(10)2954890
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 09/08/2023
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? Yes
Device Operator Lay User/Patient
Device Expiration Date05/31/2023
Device Model NumberN/A
Device Catalogue Number01.00406.118
Device Lot Number2954890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/01/2023
Initial Date FDA Received08/25/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2018
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
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
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