MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 16X152MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

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.

Event Description

It was reported that as the nurse was opening the implant package, it was found that the product was protruding out of the inner sterile package.Surgery was completed with another device, no delay to surgery.No harm to patient.Attempts have been made and no further information has been provided.

Event Description

Attempts have been made and no further information has been provided.

Manufacturer Narrative

Udi: (b)(4).

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows the outer sterile barrier to be damaged.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to blister variable wall thickness and no head-space in the shelf carton causing the blisters to deform.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.

• Brand Name: TPRLC 133 T1 PPS HO 16X152MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8706059
• MDR Text Key: 148313838
• Report Number: 0001825034-2019-02600
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

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: 51-104160
• Device Lot Number: 6246574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 12/03/2019
• Supplement Dates FDA Received: 07/12/2019; 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1