MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BIOMET COCR FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.It was reported, one month post operative, an intra prosthetic dislocation (head disassociated from bipolar liner) occurred.The surgical technique of the product was utilized, and no contributing conditions related to the event.
Additional Manufacturer Narrative
(b)(4).D10: 11-165208 ringloc bi-polar 28x42mm 66081532.G2: foreign: taiwan.Proposed 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.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.Product was returned and evaluated.A visual examination of the returned product identified scratches on the spherical surface from attempted use.Indentations were also noted on the circumference at the taper hole opening.No other damage was noted.Product identifiers for overall height and spherical diameter were measured and found to meet product specifications.Root cause remains unchanged.A definitive root cause cannot be determined.This complaint cannot 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
No further event information is available at the time of this report.

• Brand Name: ZIMMER BIOMET COCR FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER
• Common Device Name: PROSTHESIS, HIPS
• 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: 19330051
• Report Number: 0002648920-2024-00141
• Device Sequence Number: 15206056
• Product Code: LPH
• UDI-Device Identifier: 00889024498778
• UDI-Public: (01)00889024498778(17)330604(10)66054344
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 802202801
• Device Lot Number: 66054344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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 Age: 87 YR
• Patient Sex: Female