MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC; PROSTHESIS, HIP

Model Number 51-107150

Device Problem Problem with Sterilization (1596)

Patient Problem No Information (3190)

Event Date 11/22/2019

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that implant was open for implantation and the sterile packaging was damaged and the sterility was compromised.Another implant was used.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

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.The product was returned without the packaging and no photographs have been provided before the device was opened.The dhr was reviewed and no discrepancies relevant to the reported event were found.The risk associated with the damaged sterile packaging is addressed in the input output risk table ¿ sterile device packaging, revision 3.The likely condition of the device when it left zimmer biomet, and the root cause of the reported event cannot be determined as the product was returned without the packaging and no photographs have been provided.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.

• Brand Name: TPRLC
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9498268
• MDR Text Key: 196463679
• Report Number: 0001825034-2019-05649
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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: 51-107150
• Device Lot Number: 3612808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1