MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TL 133 MP SP 12/14 BM HO 5.0; 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 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: report source italy.Product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip procedure, upon opening the package of a femoral hip stem, it was found that the stem had punctured through the sterile packaging.A new product was used to complete the surgery.There was no direct contact with the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photo identified damage to the sterile packaging (blister and pouch).Sterility has been compromised.The reported event has been confirmed by review of the provided photo.Review of the device history records 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 and a packaging design issue.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirmed damage to the sterile packaging and sterility is compromised.Return of the product does not alter the previous investigation as the root cause remains attributed to transit damage and a packaging design issue.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 information.

• Brand Name: TL 133 MP SP 12/14 BM HO 5.0
• Type of Device: PROSTHESIS, 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: 16713279
• MDR Text Key: 313110488
• Report Number: 0001825034-2023-00783
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304512597
• UDI-Public: (01)00880304512597(17)280818(10)6364660
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

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: 51-139050
• Device Lot Number: 6364660
• 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: 04/02/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 07/20/2023
• Supplement Dates FDA Received: 06/13/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2018
• 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