MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TM SHELL CLUST 56 KK; PROSTHESIS, HIP

Catalog Number	00875705601
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the curved impactor failed and the cup could not be removed from the impactor.Another was used to complete the procedure.There was no harm or health consequences to the patient.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: inserter: 0001822565-2023-02902 d10: cat #: 00780402520 / hybrid offset shell inserter / lot # 61841093 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Visual examination of the returned product identified the shaft and strike plate of the device have impact marks.The threaded tip of the shaft has fractured along with the bolt.When the hex is turned the threads do not turn with it.The bolt is hidden so no photos were able to be taken.Due to the fracture the threads were not evaluated with a gauge.The shell show no visible damage.Due to the shell being used no further analysis was done on the threads.The complaint was confirmed based on the evaluation of the returned products.Dhr was reviewed and no discrepancies related to the reported event were found.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
No additional event information to report at this time.

• Brand Name: CONTINUUM TM SHELL CLUST 56 KK
• 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: 17974396
• Report Number: 0001822565-2023-02903
• Device Sequence Number: 11642295
• Product Code: JDI
• UDI-Device Identifier: 00889024151437
• UDI-Public: (01)00889024151437(17)330612(10)65966851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 00875705601
• Device Lot Number: 65966851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Patient Sex: Unknown