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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, S, -4, TAPER 12/14-18/20 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, S, -4, TAPER 12/14-18/20 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Pain (1994); Depression (2361); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: zimmer mmc cup, uncemented, 56 mm/48 mm, code n; catalog#: 01. 00634. 056; lot#: 2564524. Metasul ldh, head, 48, code n, taper 18/20; catalog#: 01. 00181. 480; lot#: 2551767. Femoral stem beaded fullcoat 12/14 neck taper std. Body std. Offset size 11 11 mm distal dia. 160 mm length; catalog#: 00-7843-011-06; lot#: 61710257 therapy date: (b)(6) 2020. The manufacturer did not receive x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. 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 the right side and underwent revision surgery due to pain, swelling, elevated metal ion levels, pseudotumor, osteolysis and metallosis.
 
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Brand NameMETASUL LDH, HEAD ADAPTER, S, -4, TAPER 12/14-18/20
Type of DeviceDUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
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 Key11957637
MDR Text Key256501827
Report Number0009613350-2021-00263
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2015
Device Model NumberN/A
Device Catalogue Number01.00185.145
Device Lot Number2565568
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2010
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: 06/08/2021 Patient Sequence Number: 1
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