MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN DUROM ACETABULAR COMPONENT; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Metal Related Pathology (4530)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that the initial unknown laterality total hip arthroplasty performed.Subsequently, the patient was revised due to allegations of metallosis and pseudotumor.No further details have been provided.Due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

(b)(4).G2- (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : item number and lot number unknown.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned for visual examination.The device is used for treatment.A review of the device history records did not identify any deviations or anomalies during manufacturing.No evaluation of the pictures/x-rays as the reported event.According to the received surgical reports, the reported event can be confirmed.No further investigation required as this issue is known and addressed in capa (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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN DUROM ACETABULAR COMPONENT
• Type of Device: HIP PROSTHESIS
• 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: 17264318
• MDR Text Key: 318492286
• Report Number: 0009613350-2023-00369
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/26/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female