MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: metasul ldh, head, 42, code h, taper 18/20; item# 0100181420; lot# 2445088.Metasul ldh, head adapter, l, +4, taper 12/14-18/20; item# 0100185147; lot# 2476729.Cls spotorno, stem, 135â°, uncemented, 8.0, taper 12/14; item# 290039080; lot# 2480672.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.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on right side and underwent revision surgery due to pain, loosening and movement limitation.

Manufacturer Narrative

Additional information which was received on oct 02, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on right side and underwent revision surgery due to pain, loosening and movement limitation.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Dhr review: the quality records indicate that this component met all requirements to perform as intended.Review of event description: patient underwent revision due to pain, loosening and movement limitation.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 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 (b)(6) (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.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 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.Therefore, zimmer gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: DUROM ACETABULAR COMPONENT
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10598832
• MDR Text Key: 209113614
• Report Number: 0009613350-2020-00431
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.048
• Device Lot Number: 2446423
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 45