MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR BIPOLAR CUP; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00500105028, lot# 65823703, liner 28 mm i.D.For use with 50/51/52 mm o.D.Shells.Cat# 802202802, lot# 3151441, femoral head 12/14 taper 28 mm diameter +0 mm neck length.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 approximately two days post-implantation, the patient underwent a hip revision following a fall due to dislocation.The shell dislocated from the acetabulum.The shell, liner, and head were revised to increase stability with a constrained cup.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified the explanted head, bipolar liner and shell covered in bio-debris.The construct is still assembled which indicates the dislocation occurred between the shell and natural acetabulum.No further evaluation can be made.Pictures were not provided of the stem.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and review identified the following: possible malposition of the acetabular cup liner on the initial image with horizontal orientation.Of note, there is partial withdrawal of the femoral component from the bone on the second image.Dislocation of both the femoral head and cup liner superiorly and likely posteriorly.A definitive root cause cannot be determined.It was reported the patient fell, however, the reason for the fall is unknown.It is unknown if the stem withdrawing from the bone is a result of the dislocation or a contributing factor of the dislocation.This complaint was confirmed based on the provided mmi report.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: MULTIPOLAR BIPOLAR CUP
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19643569
• Report Number: 0002648920-2024-00210
• Device Sequence Number: 7734061
• Product Code: KWY
• UDI-Device Identifier: 00889024115484
• UDI-Public: (01)00889024115484(17)330618(10)66068310
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/01/2024

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 Model Number: N/A
• Device Catalogue Number: 00500105200
• Device Lot Number: 66068310
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG