MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 56/50 P; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 10/14/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain.The durom cup products began shedding metal debris in his body, causing exposure to toxic metals, including cobalt and chromium.These multiple surgeries caused patient to suffer significant injuries, including great pain and agony that restricted his ability to engage in the physical activities he enjoys.

Manufacturer Narrative

Therapy date: (b)(6) 2020.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (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 did not receive x-rays for review.The manufacturer received several reports from the lawyer which will be reviewed during investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 a revision surgery was performed due to pain.The durom cup products began shedding metal debris in his body, causing exposure to toxic metals, including cobalt and chromium.These multiple surgeries caused patient to suffer significant injuries, including great pain and agony that restricted his ability to engage in the physical activities he enjoys.Update: revision due to pain, osteolysis and elevated metal ions.

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: right side: main product: durom acetabular component: ref: (b)(4); lot: 2432818; associated products: metasul ldh head, ref: (b)(4); lot:2431455; metasul ldh head adapter, ref: (b)(4); 146, lot:2462033; femoral stem, ref: (b)(4); lot 60738920; event update: revision due to pain, osteolysis and elevated metal ions; patient info: dob: (b)(6) 1950.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00041.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.It was reported that the durom cup products began shedding metal debris in his body, causing exposure to toxic metals, including cobalt and chromium.Revision surgery required.Based on the surgical reports received, the reported event can be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Device is used for treatment.The product combination used in this complaint is considered compatible.Review of complaint history identified additional similar complaints for the reported item number.Complaints are monitored through monthly complaint review (reference wt-wi 423801 monthly complaint trending) in order to identify potential adverse trends.A definite cause could not be identified.No preventive or corrective action required.Product is no longer sold since 2010.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

No change to previously reported event.

• Brand Name: DUROM US ACET CMPNT 56/50 P
• 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: 13342941
• MDR Text Key: 284443094
• Report Number: 0009613350-2022-00041
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.156
• Device Lot Number: 2432818
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male