MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00811405000 ¿ femoral stem ¿ 64237687.00801102020 ¿ cement plugs ¿ 64221887.Report source (b)(6).Customer has indicated that the product will not be returning to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00054.
Event or Problem Description
It was reported that a patient underwent a hip revision approximately 3 years post implantation due to dislocation.The head and poly cup were removed and replaced with new product.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Reported event is unable to be confirmed due to limited information provided by the customer.Device history record was reviewed and no discrepancies were found.The root cause is unable to 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.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13757217
• Report Number: 0001822565-2022-00721
• Device Sequence Number: 19453273
• Product Code: LPH
• UDI-Device Identifier: 00889024144682
• UDI-Public: (01)00889024144682(17)290131(10)64192988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 04/06/2022

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: 00801803203
• Device Lot Number: 64192988
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Female