MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: australia.D10: cat# 110024463, lot# 536020 g7 dual mobility liner 42mm e, cat# ep-200148, lot# 483760 act artic e1 hip brg 28x42mm, cat# 110010244, lot# 7210423 g7 osseoti 3 hole shell 52mm e, cat# 010000999, lot# 6478740 g7 screw 6.5mm x 30mm, cat# 010000999, lot# 7055643 g7 screw 6.5mm x 30mm, cat# 00811400200, lot# 65179060 femoral stem 12/14 neck taper std.Offset size 2 130 mm, cat# 00801102020, lot# 64590495 allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter.Customer has indicated that the product 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 approximately 2 years post implantation of a right total hip arthroplasty, the patient was revised due to dislocation.The dislocated hip was due to a glute injury, which was initially repaired during the primary procedure.An attempt was made at a closed reduction of the hip; however, during the closed reduction, the bearing separated from the head and lodged in glute soft tissue.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.H6: component code: mechanical (g04) head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: eccentric position of the femoral head within the acetabular cup consistent with the reported bearing disassociation and displacement.A definitive root cause cannot be determined.This complaint was confirmed based on the provided radiograph review confirming the reported event.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 event information is available at the time of this report.

• Brand Name: ZIMMER FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH
• 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: 19962893
• Report Number: 0001822565-2024-02620
• Device Sequence Number: 8731991
• Product Code: LPH
• UDI-Device Identifier: 00889024498785
• UDI-Public: (01)00889024498785(17)310331(10)3068754
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/13/2024

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: 802202802
• Device Lot Number: 3068754
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 83 KG