MAUDE Adverse Event Report: ZIMMER, INC. BIGLIANI/FLATOW OFFSET MODULAR HUMERAL HEAD

Catalog Number 00430205230

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It is reported that the inner packaging was compromised.The devices were not implanted.

Manufacturer Narrative

Evaluation summary: lots 60820209 and 60834818 have potential field ages of approximately 8 years and 2 months; lot 61038633 has a potential field age of approximately 6 years and 6 months.It is unknown how many times the devices were transported since manufacture.No other complaints of any type have been reported for these lots.The packaging damage is most likely due to repeated aggressive handling during the devices time in the field however, an exact cause could not be determined at this time.Evaluation: as returned the outer packaging on all three lots show damage indicative of handling and shipping.Additionally the outer cavities of all three lots are fractured; the inner cavity is fractured on lot 60820209.Device history records indicate all components were manufactured and inspected to specification.

• Brand Name: BIGLIANI/FLATOW OFFSET MODULAR HUMERAL HEAD
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4635766
• MDR Text Key: 17221871
• Report Number: 1822565-2015-00400
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 00430205230
• Device Lot Number: 60820209
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIGILIANA/FLATOW OFFSET MODULAR HUMERAL HEAD:; BIGLIANI/FLATOW OFFSET MODULAR HUMERAL HEAD:; CATALOG #00430205233, LOT #60834818; CATALOG #00430205227, LOT #61038633
• Patient Age: 70 YR
• Patient Weight: 73