MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ø 40, CODE F; DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problem Metal Related Pathology (4530)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.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 there was a systemic metallosis and pseudotumor on mom implants.Patient involvement.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: age of patient, implantation date, medical intervention.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.The following reports are associated with this event: 0009613350-2021-00658.

Event Description

No change to event.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that patient was experiencing metalosis and developed a pseudotumor after implantation of mom implants.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: the device was discarded; therefore, a product investigation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that patient was experiencing metalosis and developed a pseudotumor after implantation of mom implants.No additional information such as surgical reports, x-rays or other additional documentation was provided.A field safety notice (10-2009-001) was issued to all durom acetabular cup surgeons of record outside the u.S.Detailing the results of this investigation and emphasizing the importance of using the prescribed surgical technique.Enhanced surgical techniques were also issued to further emphasize proper technique with an additional warning statement, already documented in the instructions for use which accompanies the devices.Verification of training was required from each surgeon.Failure to verify completion of the training by the required date resulted in the surgeon being denied access to the durom acetabular cup.Implantation of the product was after the implementation of the mentioned fsn.The product is no longer available on the market since 2013.Based on the information at hand, we were not able to identify a specific root cause.The investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• Brand Name: METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ø 40, CODE F
• 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: 12966771
• MDR Text Key: 281972201
• Report Number: 0009613350-2021-00658
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

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: 11/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.046
• Device Lot Number: 2420833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 11/16/2021; 04/29/2022
• Supplement Dates FDA Received: 01/13/2022; 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR