MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 12X144MM; 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 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during total hip arthroplasty when the stem was opened the inner package had a black discoloration where the stem had torn through.Surgeon and tech felt sterilization may be compromised.Additional unit was opened and had intact inner package.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d4, d10, g4, h2, h3, h4, h6 reported event was confirmed by visual examination of device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.Visual evaluation of the returned product identified that there is a tear in the sterile pouch, and black debris consistent with porous material has been identified inside the sterile package.The complaint has been confirmed by visual evaluation.The product was likely conforming when it left zimmer biomet control.This reported event falls within the scope of a previous corrective action, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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

No further event information available at the time of this report.

• Brand Name: TPRLC XR T1 PPS 12X144MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10436616
• MDR Text Key: 203855361
• Report Number: 0001825034-2020-03283
• Device Sequence Number: 1
• Product Code: LPH
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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: 51-105120
• Device Lot Number: 3943864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1