MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 0 DEGREE FACE ANGLE 32MM I.D. CEMENTED LINER; PROSTHESIS, HIP

Catalog Number	00710505432
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown bioball ceramic head (competitor).G2: foreign ¿ australia.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 right hip revision approximately 7 years post implantation due to dislocation.During the revision the liner was found damaged due to recurrent stress and eventual failing of rim and liner.The head and liner were revised.It was confirmed that no further information could be provided.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual examination of the provided pictures identified the revised liner covered in bio debris with multiple fragments of the liner fractured off around the rim.No further observations could be made based on the image alone.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.The reported products were reviewed for compatibility, and it was determined that the following implants are not compatible: zb liner and bioball head.Medical records were not provided for the current revision.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty exhibiting slight asymmetric positioning of the femoral head component within the acetabular cup, consistent with superior polyethylene wear or damage.A definitive root cause cannot be determined.However, an off-label use was identified as zb implants were used in conjunction with competitor products.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.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: 0 DEGREE FACE ANGLE 32MM I.D. CEMENTED 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: 24011120
• Report Number: 0001822565-2026-00107
• Device Sequence Number: 9250214
• Product Code: JDI
• UDI-Device Identifier: 00889024129061
• UDI-Public: (01)00889024129061(17)221130(10)63781047
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/13/2026

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 00710505432
• Device Lot Number: 63781047
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female