MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 16X152MM MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported, while investigating circulated items in stock that some of the sterile packaging was damaged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.The complaint has been confirmed by visual evaluation.Visual evaluation of the returned products identified that the outer sterile cavities have been damaged.Sterility has been compromised on lot 2990162.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of complaint history identified additional complaints for the reported issue which is being addressed in ca-03419.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.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 additional information for this event at the time.

• Brand Name: TPRLC XR T1 PPS 16X152MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9834869
• MDR Text Key: 189337126
• Report Number: 0001825034-2020-01092
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304491861
• UDI-Public: (01)00880304491861
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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 Expiration Date: 03/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-105160
• Device Lot Number: 2990162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1