MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the returned product found the shrink wrap at the labeled end of the carton has been opened.The only items inside the outer carton are the stem and labels.No inner packaging was returned.Due to the lack of inner packaging, unable to determine if the sterility had been compromised.Device history record (dhr) was reviewed and no discrepancies were found.Root cause is due to transit damage.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

Returned goods classification code vc, packaging damage with sterility barrier potentially compromised.

• Brand Name: TAPERLOC POR FMRL 9X137
• 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: 11348041
• MDR Text Key: 232534521
• Report Number: 0001825034-2021-00536
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304185302
• UDI-Public: (01)00880304185302(17)281013(10)707760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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: 103203
• Device Lot Number: 707760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2018
• 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