MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER -6 MM NECK LENGTH; PROSTHESIS, HIP

Catalog Number	802403601
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848); Aseptic loosening (4883)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item 01.00101.914 lot 3187514 wagner sl revision stem 135 nk angle 14mm x 190mm.Item 11-107023 lot 66961702 freedom constr.Liner +5 sz 24.Item bh-110 lot 01243013 avitus bone harvester - 8 mm.H6: proposed component co.De : mechanical (g04) - head.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, patient underwent a third left hip revision due to aseptic loosening approximately 8 (eight) months later.During the revision, the cup was found to be grossly loose and removed without difficulty, femoral stem was also noted to be loose.All implants were revised without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing for the screw and head.The root cause of the reported event is related to off label use, as the surgeon used implants as spacer devices.It was also noted the shell was 'roughed up to create cement holes and grooves using a high speed burr' likely indicating the cup was not meant to be cemented.As the cup used is unknown, the surgeon has used the g7 cup multiple times for this patient.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.

• Brand Name: CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER -6 MM NECK LENGTH
• Common Device Name: PROSTHESIS, HIP
• 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: 23638443
• Report Number: 0001822565-2025-04285
• Device Sequence Number: 9765727
• Product Code: LPH
• UDI-Device Identifier: 00889024499065
• UDI-Public: (01)00889024499065(17)340911(10)3206835
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 802403601
• Device Lot Number: 3206835
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 H1.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White