MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEM CONST LNR 50X28; PROSTHESIS, HIP

Catalog Number	00711505028
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H10: unknown head.Unknown cup.Unknown stem.G2: japan.The customer indicated that the product location is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 1-year post implantation due to dislocation.During the procedure, the liner and head were revised successfully.It was confirmed that no further information could be provided.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h4; h6; h10.Visual examination of the provided pictures identified the constrained liner and ring within the joint, and then the explanted ring, covered in bio-debris.The ring and liner appear to still be assembled within the joint after the dislocation.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1.Right total hip arthroplasty with cup-cage construct and constrained acetabular cup liner.2.Femoral head component and acetabular cup constrained liner are dislocated.3.Generalized reduced bone mineral density.Bony deficiency of the proximal femur about the proximal femoral.Stem.Radiolucent lines at metal-bone interfaces of the proximal femoral stem are possible for loosening of the femoral component.4.Heterotopic islands of bone project lateral to the hip.A bony fragment projecting medial to the proximal femoral stem may be heterotopic island of bone versus old ununited fracture of the proximal medial femoral shaft.A definitive root cause cannot be determined.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.

• Brand Name: CEM CONST LNR 50X28
• 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: 23584823
• Report Number: 0001822565-2025-04205
• Device Sequence Number: 9305096
• Product Code: KWZ
• UDI-Device Identifier: 00889024130241
• UDI-Public: (01)00889024130241(17)290302(10)66379610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072121
• 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): 03/26/2026

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: 00711505028
• Device Lot Number: 66379610
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female