MAUDE Adverse Event Report: ZIMMER GMBH B-S REINFORCEMENT RING NEW, 50 RIGHT; BURCH/SCHNEIDER REINFORCEMENT CAGE

Catalog Number 01.00191.250

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/27/2012

Event Type  Injury  

Event Description

A product liability claim was raised.It was reported that the pt was implanted with a b-s reinforcement ring new, 50 on the right side on (b)(6) 2011.The pt needed to be revised on (b)(6) 2012 due to loosening of the burch schneider cage and metallosis.

Manufacturer Narrative

The manufacturer did not receive explanted devices for review.The lot number was received for the device, the device history records were reviewed and found to be conforming.Up to now, no confirmation is possible that the reported zimmer device was affected.However, according to the provided info the current situation reflects an off-label use.The product combination with a non-zimmer product is not approved and recommended by zimmer at all.As soon as add'l info become available and an investigation result be available, an amended medical device report will be submitted.Zimmer ref no: cpt(b)(4).Note: this pt was revised several times (reported under referenced files cpt(b)(4), cpt(b)(4), cpt(b)(4), cpt(b)(4), cpt(b)(4)) and this new case was opened after receival of new info from supplemental documents.

• Brand Name: B-S REINFORCEMENT RING NEW, 50 RIGHT
• Type of Device: BURCH/SCHNEIDER REINFORCEMENT CAGE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 4218656
• MDR Text Key: 4974933
• Report Number: 9613350-2014-04060
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 01.00191.250
• Device Lot Number: 2562192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR