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

Catalog Number	00877503202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Ref 00630505032 lot 66070576 longevity liner.Ref 00784802300 lot 66528181 kinectiv neck g.Ref 00620205222 lot 66624520 tm modular cup 52mm.Ref 00625006520 lot 66814859 screw 6.5x20mm.Ref 00625006520 lot 66791366 screw 6.5x20mm.Ref 00771300700 lot 66483312 m/l taper kinectiv stem 7.5 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 that a patient had a right total hip arthroplasty.Subsequently, the patient was revised, approximately 2 months post implantation, due to instability and recurrent dislocations.During the revision, the surgeon noted that the posterior capsule was already traumatically removed, and the hip was dislocating in the sleeping position.The acetabular component was well-fixed and in appropriate position.The femoral component was found lacking anteversion but was well-fixed and therefore not revised.The head and liner were replaced with constrained components without complications while all other implants remained intact.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.Medical records were provided and reviewed by a health care professional.The patient is female and was born in 1959 (bmi 30.37).The patient underwent an initial right tha due to osteoarthritis.Subsequently, the patient underwent revision surgery, due to instability and recurrent dislocations.During the procedure, the surgeon observed that the posterior capsule had already been traumatically removed, and the hip was dislocating while the patient was in a sleeping position.The acetabular component was well-fixed and appropriately positioned.Although the femoral component lacked anteversion, it remained securely fixed and was not revised.The head and liner were successfully replaced with constrained components without complications, while all other implants remained intact.Based on the available information, the reported event can be confirmed, but a definitive root cause cannot be established.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
Diligence is completed and no further information on the reported event has been provided.

• 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: 21358601
• Report Number: 0009613350-2025-00052
• Device Sequence Number: 18255764
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)340112(10)3182100
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00877503202
• Device Lot Number: 3182100
• 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: 12/22/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG