MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 16.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the inner packaging of the implant looked shrunken or melted upon opening.Another implant was used to complete the surgery.There was no known impact or consequences to the patient.No further information has been provided.

Manufacturer Narrative

(b)(4).Visual evaluation of the returned product found the sterile blister exhibits damage consistent with thermal damage.Sterility has been breached as the tyvek seal has lifted.This complaint has been confirmed by evaluation of the returned product.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 considered non-conforming to specification.The root cause of the reported event can be attributed to packaging operator not following the work instructions provided.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: TPRLC 133 MP TYPE1 PPS SO 16.0
• 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: 18194589
• MDR Text Key: 328827344
• Report Number: 0001825034-2023-02762
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304514393
• UDI-Public: (01)00880304514393(17)320407(10)7220550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

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: 51-106160
• Device Lot Number: 7220550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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
• Patient Sex: Male