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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Reported event was confirmed by examination of the device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage for the white foam and black porous coating debris.The foreign debris is a result of the operator not following work instructions provided, and is defined as non conforming when the device left zimmer biomet.Evaluation of the returned product/photographs provided confirmed the following: lot #3721973: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.In addition, a hair like debris was found between the foam insert and sterile blister.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 debris in their sterile package.No patients were involved.No additional information is available.

• 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: 10683908
• MDR Text Key: 211556126
• Report Number: 0001825034-2020-03819
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304512313
• UDI-Public: 00880304512313
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120030
• 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: 10/14/2020

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: 51-100040
• Device Lot Number: 3721973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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