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

Catalog Number	110031010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip procedure approximately two years post implantation due to a dislocation.This was corrected with noniterative repositioning.No implants were removed.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02016.G2: japan.D10: cat #: 110024462 / g7 dual mobility liner 40mm d / lot #: 967890.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm the complaint as no product was returned, images or medical records were provided.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.It is unknown if the patients fall cause or contributed to the event or if the implants caused/contributed to the fall.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
No additional event information to report at this time.

• Brand Name: 28MM I.D. 40MM O.D. SIZE D BEARING
• 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: 17641007
• Report Number: 0001822565-2023-02284
• Device Sequence Number: 8021906
• Product Code: LPH
• UDI-Device Identifier: 00889024572683
• UDI-Public: (01)00889024572683(17)250630(10)64782523
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 06/30/2025
• Device Catalogue Number: 110031010
• Device Lot Number: 64782523
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2020
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown