MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. 40MM O.D. SIZE D BEARING; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 years and 5 months post implantation due to dislocation.At the time of the surgery, the dual mobility liner was off head and bearing.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 650-1055, item name: cer bioloxd option hd 28mm, lot #: 3050659.G2: foreign: japan.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the bearing with some nicks and gouges around the rim.Without product return, further evaluation is not possible.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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 for trends.
Event or Problem Description
There is no update to the prior event description provided.

• Brand Name: 28MM I.D. 40MM O.D. SIZE D BEARING
• Common Device Name: PROSTHETIC, 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: 19086636
• Report Number: 0001822565-2024-01216
• Device Sequence Number: 20722588
• Product Code: LPH
• UDI-Device Identifier: 00889024572683
• UDI-Public: (01)00889024572683(17)260621(10)65099356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 07/26/2024

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: Health Professional
• Device Expiration Date: 06/21/2026
• Device Model Number: N/A
• Device Catalogue Number: 110031010
• Device Lot Number: 65099356
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose