MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2023

Event Type  malfunction  

Event Description

It was reported that the implant had pierced through the sterile packaging.There was about a 20 min delay in surgery to prepare the canal for a new implant.There was no harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source canada.Product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Visual evaluation of the returned product found the stem punctured through both the inner and outer sterile blister causing additional damage to the paperboard carton.Sterility has been breached.This complaint has been confirmed by review of the returned product.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.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 Description

No additional event information to report at this time.

• Brand Name: FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• 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: 16500922
• MDR Text Key: 310855608
• Report Number: 0002648920-2023-00037
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 008809024140110
• UDI-Public: (01)008809024140110(10)300906(10)64776054
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K210842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00787101761
• Device Lot Number: 64776054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1