MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL STEM 9 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Lot #64063155 exhibited a damaged outer tyvek lid so the sterility is compromised.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the parts when they left zimmer biomet control is considered conforming based on the evaluation of the returned products, the dhrs review, and the potential transit age of the devices (20 months).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

It was reported that upon inspection in the (b)(6) warehouse, that the package was damaged.No patient involvement.No additional information.

• Brand Name: MODULAR HUMERAL STEM 9 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10213587
• MDR Text Key: 197790503
• Report Number: 0001822565-2020-02339
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024263819
• UDI-Public: (01)00889024263819(17)280630(10)64063155
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2020

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: 00430000913
• Device Lot Number: 64063155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1