MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DURASUL® CONSTRAINED INSERT SIZE 38MM/67MM; PROSTHESIS, HIP

Catalog Number	438038067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately eight years post implantation, the patient is experiencing high levels of pain and difficulty ambulating.No revision has been scheduled to date.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Mdr reports were filed for this event, please see associated reports: 0001822565-2023-02763, 0001822565-2023-02764, 0001822565-2023-02766.D10: unknown head; unknown stem; unknown cup.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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4; b5; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: in initial right tha was performed approximately eighteen years ago with unknown implants.A revision occurred approximately seven years ago due to dislocation, elevated ions, and tissue damage.To date, the patient is still experiencing pain and has been using trekking poles for stability.No revision has been reported.The complaint is confirmed based on review of the provided medical records.A definitive root cause is unable to 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.

• Brand Name: DURASUL® CONSTRAINED INSERT SIZE 38MM/67MM
• 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: 17897372
• Report Number: 0001822565-2023-02765
• Device Sequence Number: 3379735
• Product Code: JDI
• UDI-Device Identifier: 00889024169708
• UDI-Public: (01)00889024169708(17)210930(10)63451375
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2021
• Device Catalogue Number: 438038067
• Device Lot Number: 63451375
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 01/02/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/07/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: Other
• Patient Sex: Male