MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER BIOMET COCR FEMORAL HEAD 12/14 TAPER 28 MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00711004828 lot# longevity 10 degree face angle 28mm i.D.Oblique cemented shell liner.G2: foreign: country: australia.H6: component code: mechanical (g04) - head.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.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.The reported event could not be confirmed.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
It was reported that approximately 4 months post implantation of a total hip arthroplasty, the patient was revised due to dislocation.It was reported that the patient dislocated several times post-surgery.The patient was then sent to rehab until a date for surgery was determined by the surgeon.The patient had a revision of poly liner and femoral head.It is unknown if there were any contributing conditions.No additional information available.

• Brand Name: ZIMMER BIOMET COCR FEMORAL HEAD 12/14 TAPER 28 MM
• 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: 20386048
• Report Number: 0001822565-2024-03196
• Device Sequence Number: 8037479
• Product Code: LPH
• UDI-Device Identifier: 00889024498785
• UDI-Public: (01)00889024498785(17)340110(10)3185735
• 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: 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
• Report Date (Section B): 10/07/2024

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: 3185735
• 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: 07/03/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 86 KG