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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Deformity/ Disfigurement (2360); Unequal Limb Length (4534)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX OPTION HEAD SYSTEM
• Common Device Name: 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
• Report Number: 0009613350-2023-00670
• Device Sequence Number: 3890657
• Product Code: LZO
• UDI-Device Identifier: 00889024430433
• UDI-Public: (01)00889024430433(17)321114(10)3137218
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG