MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY 10DEG LNR 32MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported when sterile liner was opened for the case, they discovered a hair inside the implant.There was no delay in surgery.Another cup was used.No additional information.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual review of the provided pictures and returned device confirmed the presence of a hair-like fiber on the liner.No packaging was returned with the device.The hair-like fiber has an approximate length of 40mm.No other anomalies were noted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The likely condition of the part when it left zimmer biomet control cannot be evaluated.It cannot be determined if the hair-like fiber was introduced in the transparent inner sterile cavity before or after the product was fully opened.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

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

• Brand Name: G7 LONGEVITY 10DEG LNR 32MM C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10489834
• MDR Text Key: 205713201
• Report Number: 0001825034-2020-03418
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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: 20113203
• Device Lot Number: 64626699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 61 YR