MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN HEAD 32; HIP IMPLANT

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problem Sepsis (2067)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that there was a revision to replace the head and liner due to sepsis.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2: foreign: ireland.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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 -00616 h3 other text : product information unknown.

Event Description

It was reported that there was a revision to replace the head and liner due to sepsis after approximately (2) months of implantation.Due to intraoperative complications product removal did not happen.Due diligence has been completed for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.All products manufactured follow appropriate standards, and the reported infection occurred > 90 days; therefore, implanted products are not identified as the source or contributing to the reported infection.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 HEAD 32
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18094625
• MDR Text Key: 327661199
• Report Number: 0009613350-2023-00615
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 12/19/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HEAD 32
• 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: 10/26/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/19/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Required Intervention