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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20 HIP PROSTHESIS, INTERNAL, FEMORAL COMPONENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20 HIP PROSTHESIS, INTERNAL, FEMORAL COMPONENT Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
Medical product: zimmer mmc, cup, uncemented, 56 mm/48 mm, code n; item# 0100634056; lot# 2528553; metasul ldh, head, 48, code n, taper 18/20; item# 0100181480; lot# 2543942; fitmore, hip stem, uncemented, b/7, taper 12/14; item# 0100551207; lot# 2538809. Therapy date: (b)(6) 2021. The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation. 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 was revised due to massive acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood.
 
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Brand NameMETASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
Type of DeviceHIP PROSTHESIS, INTERNAL, FEMORAL COMPONENT
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 Key11617892
MDR Text Key243907085
Report Number0009613350-2021-00162
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K053536
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 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2015
Device Model NumberN/A
Device Catalogue Number01.00185.146
Device Lot Number2585758
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 Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2010
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: 04/06/2021 Patient Sequence Number: 1
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