MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS LG SHT SPDL W PINS 800LBF; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Catalog Number	178370
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 9 months post implantation of a compress system, the patient experienced sudden onset pain.X-rays revealed that the anchor plug had fractured and spindle disassembled.Subsequently, the patient was revised of the compress system with a new compress system.It is noted by the reporting healthcare professional that the patient does have a high bmi that may have been a contributing cause to the event.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 178562, cps short anchor plug 20mm, lot # 063960, 178547, cps centering sleeve 25mm, lot # 65994908, 178530, cps transverse pin 6pk 44mm, lot # 813920, 178531, cps transverse pin 6pk 48mm, lot # 66150531, 178512, cps nut co-cr-mo alloy, lot # 66469877.The reported event could be confirmed via medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be made.Review of the device history records identified no deviations or anomalies related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right knee oss orthopedic compress salvage system exhibits loosening at spindle bone-metal interface, spindle screw pull-out and disassociation, and abnormal angle of anchor plug with respect to with respect to the spindle component suggests fracture of the connecting bar.Review of complaint history found no additional related issues for these items and the reported part and lot combination.A definitive root cause could not be determined.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: CPS LG SHT SPDL W PINS 800LBF
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• 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: 24503169
• Report Number: 0001825034-2026-00493
• Device Sequence Number: 13395250
• Product Code: KWA
• UDI-Device Identifier: 00880304509139
• UDI-Public: (01)00880304509139(17)331004(10)65832843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 178370
• Device Lot Number: 65832843
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 160 KG