MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884); Joint Dislocation (2374); Tissue Breakdown (2681)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent initial right hemiarthroplasty and was revised approximately 3 weeks later due to multiple right hip dislocations.Another revision was performed approximately 2 weeks later due to multiple dislocations, and approximately 2 more weeks later the patient was revised for a third time due to dislocation.During the revision a large hematoma was evacuated, and minimal necrotic tissue was noted.The surgeon has reported that the intention of the surgery was to allow for cup ingrowth to the bone and then return to surgery for final cemented stem and constrained liner.The stem and head were explanted without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): d10: item # 30124007, 40mm i.D.Size g high wall liner, lot # 66760591.Item # 0106010304, avenirâ®, stem, lateral, cemented, 4, taper 12/14, lot # 3168933.Item # 110010247, g7 osseoti 4 hole shell 58mm g, lot # 66540697.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Surgical notes for the implantation surgery was provided and reviewed by a health care professional with the following findings: ¿ it was reported that the shell liner was intact and that the head was no longer within the liner.¿ revision of femoral head and placement of shell and liner.¿ final implants, hip relocated, stability excellent.Surgical notes for the revision surgery was provided and reviewed by a health care professional with the following findings: ¿ large hematoma at least 500ml.¿ stem removed easily.¿ minimal necrotic tissue.¿ residual bone stock appeared ideal.¿ ¿posterior superior acetabulum was stripped down to white bone with complete periosteal stripping likely from the dislocations¿.¿ no evidence of short external rotators mostly likely scarred in retracted and inferior.¿ no intraoperative complications.Additional correspondence was provided stating that the intention of the surgery is to allow the cup to in-grow into the bone and then come back in four months to cement in a new stem with a constrained liner.Based on the available information, the reported event can be confirmed.The indication for revision surgery, was that the patient lost balance and fell while reaching for toilet paper, resulting in a hip dislocation.Additionally, the patient has a history of recurrent dislocations.However, based on the available information, a definitive root cause could not be determined.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.

• Brand Name: BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 20726695
• Report Number: 0009613350-2024-00542
• Device Sequence Number: 8370836
• Product Code: LZO
• UDI-Device Identifier: 00889024430563
• UDI-Public: (01)00889024430563(17)290430(10)2980145
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 00877704002
• Device Lot Number: 2980145
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 61 KG