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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Naturally Worn (2988)
Patient Problems Pain (1994); Osteolysis (2377)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products ref: 01. 00295. 008; lot: 2217964, cls spotorno, stem, 125, uncemented, 8. 0, taper 12/14, ref: 01. 00185. 146; lot: 2284973, metasul ldh, head adapter, m, 0, taper 12/14-18/20, ref: 01. 00181. 520; lot: 2274300, metasul ldh, head, 52, code r, taper 18/20. Complaint investigation - review of event description: the product was implanted on (b)(6) 2005 and revised on unknown date due to osteolysis, high cobalt value. Further diagnoses revealed massive metal abrasion (wear). - other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event. -dhr review: the quality records indicate that this component met all requirements to perform as intended. - no further due diligence required as all required information to support the conclusion is available/was already requested. Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations. As a corrective action, a retraining program for users outside the usa was initiated in (b)(6) 2009 and reported to the national competent authorities as required. The durom cup reported in this case is not marketed in the usa. A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in (b)(6) 2008 as notification z-2415/2426-2008. Conclusion no further investigation required as this issue is known and addressed in cp00000620 (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 re-evaluate the case. Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation. Therefore, zimmer gmbh considers this case as closed. Zimmer¿s reference number of this file is cmp(b)(4).
 
Event Description
It was reported that a patient underwent revision surgery due to osteolysis, high cobalt value and massive metal abrasion.
 
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Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R
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 Key10573148
MDR Text Key208119381
Report Number0009613350-2020-00419
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/15/2010
Device Model NumberN/A
Device Catalogue Number0.100214.058
Device Lot Number2270867
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 Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2005
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: 09/23/2020 Patient Sequence Number: 1
Treatment
SEE H10
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