MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Ambulation or Postural Difficulties (2544)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.G7 pps ltd acet shell 48c item# 010000661 lot# j7696942.32mm i.D.Size c neutral liner item# 20103203 lot# 66842788, femoral stem cementless collared high offset 12/14 taper size 6.5.Item# 574202065 lot# 3205483.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
It was reported that the patient underwent a revision surgery 16 days post implantation due to instability.Due diligence is in process and no additional information on the reported event has been provided.
Event or Problem Description
It was reported that the appropriate implant was selected for the patient.Subsequent to implantation, the patient experienced a periprosthetic fracture in the acetabulum.It is not known what caused the fracture.The patient was revised and a larger implant used as a result of the fracture that had occurred for better fixation.The patient is reported to be doing well after the revision surgery.It was reported that no further information is available.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.As per complaint investigation this complaint is processed as a limited investigation.Limited investigations do not need to have the dhr, raw material certificate, sterilization certificate, complaint history, product hold/field action 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.Radiographs were provided and reviewed by a radiologist.On (b)(6) 2024, the left hip arthroplasty shows anatomic alignment.An undated image reveals a fracture of the medial wall of the acetabulum with loosening of the acetabular implant and displacement of the implant components into the left hemipelvis.There is no fracture of the proximal femur.On (b)(6) 2024, interval arthroplasty revision was performed, including plate, screw, and cement fixation of the acetabular fracture.In the available image, alignment appears anatomic with no evidence of dislocation.Based on the available information, the reported event can be confirmed; however, it can be assumed that only the shell played a role on the periprosthetic fracture on the acetabulum.Therefore, the head reported in this complaint is not involved in the reported event.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® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, 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: 21042164
• Report Number: 0009613350-2024-00637
• Device Sequence Number: 8399422
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)340705(10)3200631
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• 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): 02/27/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503202
• Device Lot Number: 3200631
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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 Age: 73 YR
• Patient Sex: Female