MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. SIZE E 10A LINER; PROSTHESIS, HIP

Catalog Number	30112805
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat # 010000703 lot# 7840937 g7 bonemaster ltd acet shl 52e.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 procedure.Subsequently, the patient was revised approximately 6 weeks later due to dislocation.During the revision, the orientation of the cup was changed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; h4; h6.Visual examination of the provided pictures identified the explanted shell and liner covered in biodebris.The liner has a screw through the centre of the inner surface and is used to disassemble the liner from the shell.The shell has the screw plugs in place.No further observations could be noted for the liner from the image.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 2 ap pelvis/proximal femur radiographs are reviewed, obtained at pre-revision and post-revision time points.The prerevision radiograph shows presence of left hip total arthroplasty.Radiolucency is present at the femoral stem tip metal-bone and metal-cement interfaces which may indicate loosening.The acetabular cup lateral angle of inclination is abnormally steep.Leg length discrepancy is present, with left leg relatively short.Heterotopic bone projects just proximal to the left hip lesser trochanter and faint small heterotopic ossification projects lateral to the left hip.Post-revision ap pelvis/proximal femur radiographs shows presence of left total hip arthroplasty.The acetabular cup has been revised.The acetabular cup lateral angle of inclination is now standard.Findings are otherwise similar to the earlier pre-revision radiograph.A definitive root cause cannot be determined.The x-ray review suggests the cup inclination is a risk factor for the dislocation.The positioning of implants are at the surgeons discretion and depends on the patients anatomy.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
No further information at the time of this report.

• Brand Name: 28MM I.D. SIZE E 10A LINER
• 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: 23757222
• Report Number: 0001822565-2025-04409
• Device Sequence Number: 18684618
• Product Code: LPH
• UDI-Device Identifier: 00889024520080
• UDI-Public: (01)00889024520080(17)280220(10)65781452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190660
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 30112805
• Device Lot Number: 65781452
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: 77 YR
• Patient Sex: Unknown