MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 4.0; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Deformation (2976); Packaging Problem (3007)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported that the sterile package was damaged and the stem was found to be damaged.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified damage to the sterile packaging (blister and pouch).Sterility has been compromised.Visual evaluation of the returned product identified damage to the outer packaging.Complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event for blister and pouch damage can be attributed to transit damage, and a packaging design issue.The root cause of the reported event for outer packaging damage can be attributed to transit damage secondary to the pouch and blister damage.A corrective action has been previously raised to implement improved packaging changes.No corrective actions, preventive actions, or field actions resulted after investigation of the event reported for outer packaging 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.

• Brand Name: TPRLC 133 FP TYPE1 PPS SO 4.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14074096
• MDR Text Key: 289005525
• Report Number: 0001825034-2022-00830
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304512313
• UDI-Public: (01)00880304512313(17)290822(10)6608317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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: 51-100040
• Device Lot Number: 6608317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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