MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 11X142MM 2MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03906, 0001825034 - 2020 - 03908.Reported event was confirmed by visual examination of device.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.The root cause of the foreign debris is the operator not following the work instructions provided.The root cause of the damaged blister is likely due to transit damage.Evaluation of the returned product/photographs provided confirmed the sterile packaging blister is damaged.Further evaluation found foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.The sterility has been breached.The likely condition of the device when it left zimmer biomet is non-conforming to specification.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during an investigation of circulated items.Several devices were identified as having sterile packages damaged.Upon examination of device for reported packaging damage, it was discovered that the sterile packaging was not compromised but contained a foreign debris.No patients were involved.No additional information is available.

• Brand Name: TPRLC 133 T1 PPS HO 11X142MM 2MM 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: 10741843
• MDR Text Key: 213249814
• Report Number: 0001825034-2020-03907
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489714
• UDI-Public: 00880304489714
• 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 51-104110
• Device Lot Number: 6105011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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