MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip revision approximately 3 years post implantation due to a fall causing a dislocation.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat#010000850 lot#6489079 liner, cat#51-113140 lot#6537103 stem, cat#110010266 lot#6463340 shell.Foreign source: australia.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02421.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - head.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs provided were taken 3 months before the dislocation and were not assessed.Device history record (dhr) was reviewed and no discrepancies were found.It was reported the patient dislocated due to a fall.As the reason for the fall is unknown, a definitive root cause cannot 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.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).

• Brand Name: 32MM MOD HEAD COCR -3MM NECK
• Common Device Name: PROSTHESIS, 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: 15668417
• Report Number: 0001822565-2022-03058
• Device Sequence Number: 6372931
• Product Code: JDG
• UDI-Device Identifier: 00887868308321
• UDI-Public: (01)00887868308321(17)290626(10)64449451
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942479
• 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,Followup
• Report Date (Section B): 04/20/2023

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: 163668
• Device Lot Number: 64449451
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 04/20/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 01/24/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 86 KG