MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP 12/14 BM HO 6.0; PROSTHEIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

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 an initial hip arthroplasty , the sterile package was damaged.No adverse events have been reported as a result of the malfunction, attempts have been made and additional information on the reported event is unavailable.

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.  visual evaluation of the returned products identified that the stem has protruded through inner and outer packaging damaging both sterile cavities and the outer carton box.Sterility has been compromised.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.This product was likely conforming when it left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.This device falls within the scope of a corrective action which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this corrective action, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC 133 FP 12/14 BM HO 6.0
• Type of Device: PROSTHEIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9480802
• MDR Text Key: 196447375
• Report Number: 0001825034-2019-05598
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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: 51-131060
• Device Lot Number: 3450091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1