MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL POROUS AND BONEMASTER COATED STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign- the event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

The inner sterile packaging has been to be compromised.The surgery was completed without further incident with another device.No further information is available at this time.

Event Description

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

Manufacturer Narrative

Udi- (b)(4).Complaint sample was evaluated and the reported event was confirmed.The visual inspection of the returned product identified that the inner sterile pouch was punctured.Dhr was reviewed and no discrepancies were found.Review of complaints history search identified no other complaints reported for the same part, lot or event.The likely condition of the product when it left zimmer biomet was conforming to specifications.A definitive root cause of the reported issue cannot be determined.This product falls within the scope of corrective action that is reviewing the packaging configurations at zimmer biomet, (b)(4).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: TAPERLOC COMPLETE PRIMARY FEMORAL POROUS AND BONEMASTER COATED STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8199106
• MDR Text Key: 131610250
• Report Number: 0001825034-2018-11417
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-131180
• Device Lot Number: 3022203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1