MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X48MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# unknown lot# unknown advantage 54mm acetabular cup.G2: foreign: country: canada.Customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a cemented 54mm, competitor acetabular cup was implanted.A -6mm dm liner (48mm) was opened, only to discover it was too large.The patient had pain and suspected infection, and a stage 1 prostalac was performed.The zimmer biomet liner was placed in the cup regardless because it was a prostalac total hip arthroplasty and will need revision.The surgeon was satisfied with tighter mobility.It was reported that the liner was believed to either be mislabeled or the improper liner type was provided in the loaner kit.It might be due to it being a zimmer biomet bearing and not a competitor bearing.Regarding delay of surgery, there was some time to evaluate options, but not enough to be measured.It was reported that the patient had old worn-out implants from an old surgery.The worn-out implants were from an unspecified company but were not zimmer biomet implants.There was no reported harm or injury to the patient.No additional information is available.
Event or Problem Description
It was reported that the surgeon trialed first with provisional, but when the corresponding implant box was opened, the implant inside was larger than the provisional.It was deduced that the wrong sized implant was contained inside the box and the wrong label was included on the box.No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;b5;h2;h6 the following section was corrected: g3 customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
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.A review of the device history records identified no related 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
No further information at the time of this report.

• Brand Name: VIVACIT-E DM BEARING 28X48MM
• Common Device Name: PROTHESIS, 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: 17637819
• Report Number: 0001822565-2023-02278
• Device Sequence Number: 6481210
• Product Code: LPH
• UDI-Device Identifier: 00889024572720
• UDI-Public: (01)00889024572720(17)250827(10)64782786
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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 Expiration Date: 08/27/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031014
• Device Lot Number: 64782786
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 08/19/2023; 01/16/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/05/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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
• Patient Sex: Unknown