MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 54/48 N; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medical product: metasul® ldh®, head, 48, code n, taper 18/2; catalog#: 01.00181.480; lot#: 2314686.Metasul® ldh®, head adapter, xl, +8, taper 12/14-18/20; catalog#: 01.00185.148; lot#: 2316472.Femoral stem press-fit collarless 12/14 neck taper standard body standard neck catalog#: 00-7864-014-00; lot#: 80358389.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(6) 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 did not receive x-rays, or other source documents for review.Surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).

Event Description

It was reported that, right hip painful hip/failed arthroplasty with metal on metal articulation.Patient outcome revision due to pain.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that right hip painful hip/failed arthroplasty with metal on metal articulation.Revision surgery.Patient involved.Review of received data: no evaluation of the pictures/x-rays as the reported event is already known and addressed.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 (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 july 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).

• Brand Name: DUROM US ACET CMPNT 54/48 N
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• 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: 14102448
• MDR Text Key: 289192403
• Report Number: 0009613350-2022-00229
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.154
• Device Lot Number: 2299090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2005
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization