MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM MOD HD STD NECK TP1 TAPER; PROSTHESIS, HIP

Catalog Number	163662
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a hip dislocation after falling.A reduction was performed at the hospital by the surgeon, but the dislocation was not resolved.Subsequently, the patient underwent a revision approximately one-month post-implantation due to the bipolar cup and head detaching and dislocating.The cup and head were revised.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).D10: ringloc bipolar vit e 28x47mm.Item: 30302847.Lot: 65781633.Tprlc 133 t1 pps so 12x144mm.Item: 51-103120.Lot: j7729613.G2: japan.H6: proposed component code: mechanical (g04) ¿ head.The customer has indicated that the product is not available and will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6; h10.Visual examination of the returned product identified the liner returned still assembled within the shell.The liner of the bipolar has minor scratches on the i.D.And an indentation on the top flat surface.The head has 2 nicks around the outside chamfer.No other damage was noted during visual evaluation.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.These devices were implanted for approximately 1 month.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: image 1 out of 2 shows superolateral dislocation of a bipolar hip arthroplasty cup and femoral component out of the acetabulum.Image 2 out of 2 shows dissociation of the bipolar cup component from the femoral component.The disassociated bipolar cup remains laterally dislocated from the acetabulum while the femoral component now appears to be relocated within the acetabulum.A definitive root cause cannot be determined.It was reported that the patient had a dislocation and subsequent closed reduction leading to disassociation of the head from the ringloc components.It is unknown if the devices caused or contributed to the reported dislocation.As per ifu 01-50-1293 and ifu 01-50-0961, the ringloc bi-polar acetabular prosthesis can dislocate.Closed reduction is generally successful; however closed reduction must be attempted with caution to prevent disassociation of the bi-polar acetabular component from the femoral component.When dislocated, the bi-polar component can assume a vertical position and become impinged against the natural acetabulum.When impinged, during closed reduction, the bi-polar component can experience forces greater than the lever out forces or torque forces required to disassociate (separate) the bi-polar component from the femoral component.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 trends.
Event or Problem Description
Due diligence is complete as multiple attempts were made; however, no further information is available.

• Brand Name: 28MM MOD HD STD NECK TP1 TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23223358
• Report Number: 0001825034-2025-03101
• Device Sequence Number: 13138955
• Product Code: LPH
• UDI-Device Identifier: 00887868308277
• UDI-Public: (01)00887868308277(17)340904(10)J7824249
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 163662
• Device Lot Number: J7824249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown