MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALLEN MEDULLARY CEMENT PLUGS; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was debris in the sterile package.The product was not used per the surgeon¿s discretion.The product is available for return; however, the ¿hairs¿ have been discarded.No known impact r consequence to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D1: allen medullary cement plugs 1-16 mm diameter flange/8 mm diameter core store in cool dry place.G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual evaluation of the provided photo and returned product found no hair-like debris.It was noted by the reporter that the hair-like debris had been discarded.The device has been modified with cut marks along the circumference of the device by the hospital staff.It is noted that these cut marks were made to visually identify the device as non-usable.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for the reported part and part lot combinations.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.

• Brand Name: ALLEN MEDULLARY CEMENT PLUGS
• Common Device Name: PROSTHESIS, HIPS
• 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: 19652082
• Report Number: 0001822565-2024-02203
• Device Sequence Number: 12399443
• Product Code: JDI
• UDI-Device Identifier: 00889024432987
• UDI-Public: (01)00889024432987(17)271207(10)65651155
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/01/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00801102016
• Device Lot Number: 65651155
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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
• Patient Sex: Unknown