MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 - 01183, 0001825034 - 2018 - 01184, 0001825034 - 2018 - 01185, 0001825034 - 2018 - 01186, 0001825034 - 2018 - 01187.Product location is unknown.

Event Description

It was reported that the incoming inspection team member found debris in sterile packaging.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual inspection of the affected products' photographs.The root cause of the reported issue is a manufacturing deficiency.The work instruction i000132 rev.10 provides adequate detail instructing the operator to look for any contamination.Failure mode: process: packaging: foreign particles : particulate : debris, hair, fiber, cinder, lint.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is a manufacturing deficiency.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 XR 123 MICRO FEMORAL POROUS COATED STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7290109
• MDR Text Key: 101006605
• Report Number: 0001825034-2018-01185
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: 51-149050
• Device Lot Number: 6147950
• Other Device ID Number: (01)00880304517424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1