MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/42, CODE H; DUROM ACETABULAR COMPONENT AND METASUL LDH

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: metasulâ® ldhâ®, head adapter, l, +4, taper 12/14-18/20; catalog no#: 0100185147; lot#: 2298460.Metasulâ® ldhâ®, head, 42, code h, taper 18/20; catalog no#: 0100181420; lot#: 2298813.Femoral stem porous 12/14 neck taper cementless small; catalog no#: 00802601100; lot#: 60146569.Concomitant medical device - therapy date: (b)(6) 2019.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.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 november 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 july 2008 as notification z-2415/2426-2008.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.(b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to elevated metal ions.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.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 (b)(4).Review of event description: patient was implanted on the right side and underwent revision surgery due to elevated metal ion levels.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.Complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s instruction leaflet for endoprothesis.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 (b)(4).

Event Description

No change to previously reported event.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/42, CODE H
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10435463
• MDR Text Key: 203806685
• Report Number: 0009613350-2020-00386
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2010
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.048
• Device Lot Number: 2300913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention