MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L; DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 01/18/2018

Event Type  Injury  

Event Description

It was reported that there was a revision due to metallosis.

Manufacturer Narrative

Concomitant medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20: catalog#: 0100185145, lot#: 2408138; metasul ldh, head, 46, code l, taper 18/20: catalog#: 0100181460, lot#: 2408358.Therapy date: (b)(6) 2018.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)(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 received surgical reports and legal documents and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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).

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description it was reported that the patient underwent an initial right total hip arthroplasty performed (b)(6) 2008.The patient was revised (b)(6) 2018 due to metallosis.During the revision, the cup was easily removed due to osteolysis and partial ingrowth.The stem was found well-fixed despite some proximal lysis.No corrosion was noted.All components were replaced without complication.Review of received data: pictures, x-rays (if applicable): no evaluation of the pictures/x-rays as the reported event is already known and addressed in (b)(6).Surgical report (if applicable): according to the received surgical reports, the reported event cannot be confirmed.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: no product was returned for visual examination.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records did not identify any deviations or anomalies during manufacturing.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).Most likely root cause for the reported event is inappropriate use/implantation of the product.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 notification in (b)(6) 2008 as referenced above in h7 and h9, zimmer gmbh will close this case once again.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: DUROM US ACET CMPNT 52/46 L
• Type of Device: DUROM ACETABULAR COMPONENT
• 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 Key: 13759243
• MDR Text Key: 287185971
• Report Number: 0009613350-2022-00147
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• 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 Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.152
• Device Lot Number: 2403856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• 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 Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female