MAUDE Adverse Event Report: ZIMMER GMBH B-S REINFORCEMENT RING NEW, 50 LEFT

Catalog Number 01.00191.150

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 11/23/2012

Event Type  Injury  

Event Description

A patient is pursuing a product liability claim which will be parted in 5 cases (4 zimmer winterthur products, 1 zimmer warsaw product).This current case (b)(4) belongs to the revision surgery taken place in (b)(6) 2014 due to the metallosis in the left hip.The b-s reinforcement ring new, 60 left has been explanted.

Manufacturer Narrative

The manufacturer did not receive devices.X-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).This case is one of 5 split cases: (b)(4).

• Brand Name: B-S REINFORCEMENT RING NEW, 50 LEFT
• Type of Device: B-S REINFORCEMENT RING NEW, 50 LEFT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 57426761
• MDR Report Key: 3848301
• MDR Text Key: 4654637
• Report Number: 9613350-2014-03530
• Device Sequence Number: 1
• Product Code: KWB
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 01.00191.150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention