MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, XL, ø 36/+7, TAPER 12/14; HIP PROSTHESIS

Catalog Number	00877703604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip revision 2 months post-implantation due to dislocation.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: g7 hi-wall e1 liner 36mm g, #item 010000937, #lot 7648581.Anchor stem straight 15-135, #item 0102001452, #lot 2637025.Therapy date: (b)(6) 2025.G2: foreign source: australia.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
Follow up report (b)(4).Updated:b4, b5, d2,g1,g3,g6,h1,h2,h6.Corrected: b1.No product was returned or pictures provided; a product evaluation could not be performed.However, one image was provided showing the implant labels of the implants used during implantation.A review of the device manufacturing records confirmed no abnormalities or deviations.The reported product was reviewed for compatibility with the concomitant products shown in the provided image with no issues noted.However, as the femoral component is unknown, a compatibility review of the whole system cannot be performed.Review of the complaint history identified no additional similar complaints for the reported item one year prior to the notification date and thereafter, but an additional similar complaint for the reported part and lot combination for an unlimited timeframe.Complaints are monitored per complaint trending process.Based on the available information, the reported event cannot be confirmed and a definitive root cause cannot 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.
Event or Problem Description
No additional event information.

• Brand Name: BIOLOX® OPTION, HEAD, XL, ø 36/+7, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21699606
• Report Number: 0009613350-2025-00192
• Device Sequence Number: 7868196
• Product Code: LZO
• UDI-Device Identifier: 00889024276963
• UDI-Public: (01)00889024276963(17)251130(10)2837025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 00877703604
• Device Lot Number: 2837025
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown