MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC; HIP PROSTHESIS

Model Number N/A

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-03090.

Event Description

It was reported that the sterile package of the device was damaged.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirmed that the blisters had protrusion/dents from the implant movement.The sterility however was not compromised.The seal was still intact when products were received for investigation.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03090 - 2.

Event Description

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

• Brand Name: TAPERLOC
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7479608
• MDR Text Key: 107197320
• Report Number: 0001825034-2018-03091
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 51-103120
• Device Lot Number: 6227972
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 12/10/2018
• Supplement Dates FDA Received: 05/08/2018; 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1