MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET HIP SYSTEM MODULAR HEAD; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 51-100040 item name tprlc 133 fp type1 pps so 4.0 lot # 6435004 110031314 item name 22.2mm i.D.36mm o.D.Size b bearing lot # 65619275 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that there was a hole in the packaging so it was open.There is no additional information available at the time of this report.
Event or Problem Description
It was reported that there was a hole in the packaging so a second set of stem, head, and dual mobility liner was opened to assure safety of patient.The procedure was completed with new implants.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: a1 a2 a3 a4 b4 b5 b7 g3 g6 h2 h10.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11 no product was returned or pictures provided; visual evaluation 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET HIP SYSTEM MODULAR HEAD
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19510101
• Report Number: 0001825034-2024-01542
• Device Sequence Number: 14341286
• Product Code: JDI
• UDI-Device Identifier: 00880304256446
• UDI-Public: (01)00880304256446(17)280802(10)634430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K974558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163651
• Device Lot Number: 634430
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 09/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/17/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Patient Sex: Female
• Patient Weight: 67 KG