MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 9X137MM M T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Source: (b)(6).Multiple reports were submitted along with this report 0001825034-2021-01955, 0001825034-2021-01957, 0001825034-2021-01958.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 Description

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

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.Evaluation of the returned products confirmed damage to the sterile packaging blister, and there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility has not been compromised.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 products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.A corrective action has been previously raised to implement improved packaging changes that were determined as part of a corrective action.These packaging changes will reduce the number of transit-related packaging damage events.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided 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 XR T1 PPS 9X137MM M T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12121124
• MDR Text Key: 260055271
• Report Number: 0001825034-2021-01956
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304517103
• UDI-Public: (01)00880304517103(17)280602(10)6304501
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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: 51-105090
• Device Lot Number: 6304501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1