MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 52MM HEAD HIP MOLD W/INSERT; 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 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the packaging was opened, there was a hair inside the sterile packaging.There was no back up device of the same size available, so the surgeon implanted a smaller size.

Manufacturer Narrative

Visual inspection of the returned packaging of the product confirmed that there is a hair-like structure inside the sterile packaging.Analysis of debris identified that it is stiff like a metallic wire or bristle and is consistent with 300-series stainless steel.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.The root cause of the reported event is attributed to a trained operator error.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.

Manufacturer Narrative

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: 52MM HEAD HIP MOLD W/INSERT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6191392
• MDR Text Key: 62910028
• Report Number: 0001825034-2016-05313
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: N/A
• Device Catalogue Number: 431182
• Device Lot Number: 591240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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