MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD +3MM NK; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately 3 years post implantation due to a dislocation with an infection.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110024463 g7 dual mobility liner 42mm e lot number 774380, ep-200148 act artic e1 hip brg 28x42mm lot number 674160, 110010264 g7 osseoti multihole 52mm e lot number 6740927, 010000999 g7 screw 6.5mm x 30mm lot number 6728403, 010000997 g7 screw 6.5mm x 20mm lot number 6596552, 010000996 g7 screw 6.5mm x 15mm lot number 6601348.Report source: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00721.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, as supplemental medwatch will be submitted.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, g3, g6, h2, h3, h6: mechanical (g04) - head.H10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with superior and posterior dislocation of the femoral head with possible fracture of the distal femur, incompletely evaluated.Correlate clinically.A definitive root cause cannot be determined for the disassociation of the devices.The investigation could not verify or identify any evidence of product contribution to the reported problem of infection.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: 28MM DIA COCR MOD HD +3MM NK
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16663713
• Report Number: 0001825034-2023-00722
• Device Sequence Number: 14933602
• Product Code: JDI
• UDI-Device Identifier: 05019279400720
• UDI-Public: (01)05019279400720(17)270507(10)188580
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 06/09/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163663
• Device Lot Number: 188580
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2017
• 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
• 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: PLEASE SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 70 KG