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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® LDH®, HEAD, 48, CODE N, TAPER 18/20 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® LDH®, HEAD, 48, CODE N, TAPER 18/20 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)
Event Date 01/29/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent initial right total hip arthroplasty. Subsequently revised due to pain and elevated metal ions. During the procedure metallosis, pseudotumor, bone erosion, scar tissue, soft tissue damage and trunnionosis was encountered. The head was exchanged without complications. The stem and acetabular components remained intact.
 
Manufacturer Narrative
Medical product: (b)(6) head adapter, m, 0, taper 12/14-18/20, catalog#: 01. 00185. 146; lot#: 2482725. Zimmer mmc, cup, uncemented, 58 mm/50 mm, code (b)(6). Catalog#: 01. 00634. 058 ; lot#: 2519529. Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset, catalog#: 00-7711-011-20 ; lot#: 61365648. Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer. Zimmer gmbh (b)(6) legal department is well trained and passes all information concerning the case to our complaint handling department. As soon as supplemental information becomes available an updated report will be submitted. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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). The following reports are associated with this event: 0009613350-2022-00059; 0009613350-2022-00060. Product location unknown.
 
Event Description
It was reported that the patient underwent initial right total hip arthroplasty. Subsequently revised due to pain and elevated metal ions. During the procedure metallosis, pseudotumor, bone erosion, scar tissue, soft tissue damage and trunnionosis was encountered. The head was exchanged without complications. The stem and acetabular components remained intact.
 
Manufacturer Narrative
Medical product: metasul® ldh®, head adapter, m, 0, taper 12/14-18/20, catalog#: 01. 00185. 146; lot#: 2482725. Zimmer mmc, cup, uncemented, 58 mm/50 mm, code p. Catalog#: 01. 00634. 058 ; lot#: 2519529. Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset, catalog#: 00-7711-011-20 ; lot#: 61365648. Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer. Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department. As soon as supplemental information becomes available an updated report will be submitted. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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). The following reports are associated with this event: 0009613350-2022-00059; 0009613350-2022-00060. Product location unknown.
 
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Brand NameMETASUL® LDH®, HEAD, 48, CODE N, TAPER 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 Key13449368
MDR Text Key285809372
Report Number0009613350-2022-00058
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00181.480
Device Lot Number2437780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/09/2022
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: 02/04/2022 Patient Sequence Number: 1
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