MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 10X140MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported that during inspection of circulated products in the warehouse, the product was identified as having damaged sterile packaging.Upon initial review of the pictures provided, a hair like substance was present in the packaging.No patient involvement and no adverse consequences reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).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.

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).Sterility has not been compromised.Evaluation of the returned product confirmed there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Device history record was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the damaged packaging can be attributed to transit damage, and a packaging design issue.The root cause of the debris in sterile packaging is likely to be due to transit damage causing the foam packaging to become abraded and shed, and a packaging design issue.A corrective action was previously opened to address the reported event.This event is no longer considered reportable.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 further event information available at the time of this report.

• Brand Name: TPRLC 133 T1 PPS SO 10X140MM T1
• 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: 13731738
• MDR Text Key: 287832127
• Report Number: 0001825034-2022-00579
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489684
• UDI-Public: (01)00880304489684(17)300220(10)6743454
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• 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: 51-103100
• Device Lot Number: 6743454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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