MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14; HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells item # 00630505036, lot # 65887359.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.
Event or Problem Description
It was reported a patient had an initial left total hip arthroplasty.Subsequently, the patient underwent a revision to a constrained liner approximately 3 months later due to recurrent dislocations.The dislocation was unable to be reproduced and the surgeon indicated he felt the patient¿s prior spinal issues were contributing to the instability.The acetabular and femoral components were well fixed and left in place, while the head and liner were revised.Attempts have been made and no further information has been provided.
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.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on, (b)(6) 2023.The patient experienced two dislocations and underwent a revision 3 months after implantation.The surgeon noted the implants were in good position and that his instability may have come from his low back.The head and liner were explanted and replaced with zb products.With 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information at this time.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14
• Common Device Name: 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: 18264967
• Report Number: 0009613350-2023-00663
• Device Sequence Number: 7859462
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: (01)00889024430372(17)330420(10)3154924
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 05/09/2024

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: 00877503603
• Device Lot Number: 3154924
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 31 KG