MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.G7 osseoti 3 hole shell 52mm e item# 110010244 lot# 66744611.G7 screw 6.5mm x 25mm item# 010000998 lot# 7665792.G7 screw 6.5mm x 20mm item# 010000997 lot# 7739038.G7 screw 6.5mm x 20mm item# 010000997 lot# 7760162.36mm i.D.Size e high wall liner item# 20123605 lot# 66817707.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 extended offset item# 65771101020 lot# 66705726.G2.Report source: united kingdom.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, approximately one month later, while getting up from a chair, felt a sudden onset of pain and inability to bear weight.The emergency department confirmed the dislocation and was unable to reduce the hip.Then, the patient underwent a successful reduction under general anesthesia and all implants remain in place.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
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.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The clinical report form was provided covering the initial surgery and reviewed by a health care professional.The review identified osteoarthritis as indication for surgery.No intraoperative complications and no significant findings.Further medical records for the surgical intervention in the form of consultation notes, sae med reports and a reduction note were provided and reviewed by a health care professional.The review identified a left hip dislocation, which occurred while the patient was rising from a chair.The patient experienced sudden pain and was unable to bear weight, prompting a visit to the emergency department, where initial reduction attempts were unsuccessful.A closed reduction was successfully performed later the same day under general anesthesia.Post-reduction x-rays confirmed a satisfactory hip position.Based on the available information, the reported event can be confirmed.However, 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.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, 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: 21278384
• Report Number: 0009613350-2025-00038
• Device Sequence Number: 13091473
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)340522(10)3195169
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/03/2025

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 Catalogue Number: 00877503602
• Device Lot Number: 3195169
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 69 KG