MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION HEAD SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Deformity/ Disfigurement (2360); Unequal Limb Length (4534)

Event Date 09/21/2023

Event Type  Injury  

Event Description

It was reported a patient had a revision of a right hip prosthesis.Subsequently, approximately two weeks later, radiographic imaging displayed dissociation of the cup from the pelvis and ¿huge¿ pelvic defects.Upon follow-up, the patient reports having severe pain and assessment indicated that the right leg was shortened.A pmi product is currently being planned for the patient¿s next revision.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2: report source us.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.To date the product remains implanted; therefore, visual and dimensional evaluations could not be performed.This complaint is processed as a limited investigation.Limited investigations do not need to have the dhr or complaint history pulled and reviewed.Also, a review of the risk management file has not been completed as the product is considered unrelated to the reported event.Complaints are monitored per complaint trending process.The root cause of the reported issue is unrelated to the zimmer biomet medical device.The review from mmi (hcp) identified the reported issue being related to the acetabular component and not the femoral head ("femoral implant fit appears maintained").Therefore the root cause of the reported event is not related to the femoral head captured in this complaint.The investigation for the acetabular component is captured in linked complaint.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: BIOLOX OPTION HEAD SYSTEM
• Type of Device: PROSTHESIS, HIP
• 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: 18266928
• MDR Text Key: 329730093
• Report Number: 0009613350-2023-00670
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430433
• UDI-Public: (01)00889024430433(17)321114(10)3137218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 00877702801
• Device Lot Number: 3137218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: ACT ARTIC E1 HIP BRG 28X54MM.; G7 DUAL MOBILITY LINER 54MM I.; G7 OSSEOTI MULTIHOLE 70MM I.; TRILOGY BONE SCR 6.5X35.; TRILOGY BONE SCR 6.5X35.; TRILOGY BONE SCR 6.5X40.; TRILOGY BONE SCR 6.5X40.; TRILOGY BONE SCR 6.5X40.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG