MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM, TRILOGY IT, ALLOFIT IT, LONGEVITY; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h4; h6 the following sections were corrected: d1; d4 lot and udi visual examination of the provided pictures identified explanted devices, bio-debris present.These cannot be used to confirm the reported event.Devices not returned, further analysis cannot be made.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Single undated image reviewed and not submitted to mmi.Ap view of the left hip shows a superiorly dislocated total hip arthroplasty.A definitive root cause cannot be determined, however there was a competitor head used with a zimmer biomet liner.It's unknown if this caused or contributed to the reported event.As per ifu, it states do not use with components of any system or another manufacturer unless authorized by zimmer biomet.Complaint is confirmed.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.
Additional Manufacturer Narrative
(b)(4).D10: 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 63419029.00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 61885304.00875705402 54mm o.D.Size jj porous uncemented with multi-holes shell use with jj liners 62860999.Unknown stryker head unknown.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty and was implanted with zimmer biomet and competitor products.Subsequently, the patient was revised eight (8) years post implantation due to dislocation.The liner, shell, and screws were explanted.

• Brand Name: CONTINUUM, TRILOGY IT, ALLOFIT IT, LONGEVITY
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23350755
• Report Number: 0001822565-2025-03808
• Device Sequence Number: 8064284
• Product Code: LPH
• UDI-Device Identifier: 00889024149755
• UDI-Public: (01)00889024149755(17)210131(10)63259271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/07/2025

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875201136
• Device Lot Number: 63259271
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 105 KG