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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Depression (2361)
Event Type  Injury  
Manufacturer Narrative
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) (b)(6) legal department is well trained and passes all information concerning the case to our complaint handling department. The manufacturer did not receive devices or x-rays for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. Review of event description: patient is medically precluded due to chronic pain. Surgical report: review of surgical report did not lead to new information regarding the reported event. Other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event. No further investigation required as this issue is known and addressed in (b)(4) (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release). At least one of these error patterns is observed in this event. Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will reevaluate the case. Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation. Zimmer¿s reference number of this file is (b)(4). The following reports are associated with this event: 0009613350-2018-00509, 0009613350-2018-00510, 0009613350-2018-00511.
 
Event Description
A patient is pursuing a product liability claim. It was reported that the patient is medically precluded due to chronic pain after total hip arthroplasty. Attempts to obtain additional information have been made; however, no more is available.
 
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Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
Type of DeviceDUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER 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 Key7509911
MDR Text Key108093611
Report Number0009613350-2018-00508
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Attorney
Type of Report Initial
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2013
Device Model NumberN/A
Device Catalogue Number01.00214.050
Device Lot Number2479183
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2008
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: 05/14/2018 Patient Sequence Number: 1
Treatment
CLS SPOTORNO STEM, ITEM# 29.00.39-080, LOT# 2501228; METASUL ADAPTER, ITEM# 01.00185.146, LOT# 2494478; METASUL HEAD, ITEM# 01.00181.440, LOT# 2481324
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