MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 PPS LTD ACET SHELL 52E; Prosthesis, Hip

Catalog Number	010000663
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial hip replacement procedure, a size 51 acetabular cup was trialed for fit.Initial stability was confirmed, and the surgical team was instructed to use a size 52 acetabular prosthesis.Following implantation, the acetabular cup was also reported to be stable.After securing the cup, the ceramic liner was opened and inserted.The edges were leveled, and an impactor was used to seat the liner.However, the ceramic liner fractured during impaction.Following the ceramic liner fracture, it was discovered that the previously stable acetabular cup had become slightly loose.The surgeon immediately thoroughly irrigated the acetabulum with water and removed the entire prosthesis.After adjusting the cup angle, a new size 52 acetabular cup was implanted and secured with two screws.The replacement cup was reported to be very stable.The liner was then opened and implanted, and the procedure was completed successfully.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4) d10: biolox delta cer lnr 36mm e item: 110003634 lot: 3265707 bone screw self-tapping 6.5 mm dia.50 mm length item: 00625006550 lot: 67084885 g2: foreign ¿ china the reported device has been returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• 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 ; +1(574)526-0384
• MDR Report Key: 50882045
• Report Number: 0001825034-2026-02844
• Device Sequence Number: 9826581
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)350725(10)J7976404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 010000663
• Device Lot Number: J7976404
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Patient Sex: Unknown