MAUDE Adverse Event Report: ZIMMER GMBH METAL HEAD; UNKNOWN

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 08/18/2015

Event Type  Injury  

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.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported in a journal article that the patient received an unknown metal head on an unknown date.The patient experienced measured liner wear of 2mm or greater and was revised on an unknown date.

Manufacturer Narrative

Dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: trend analysis could not be performed as no reference number was available.Compatibility check: the compatibility check could not be performed as no product information was provided.Review of incoming information: it was reported that a patient received a natural hip press fit stem and acetabular component which were manufactured by zimmer inc, (b)(6) and metal head which was manufactured by zimmer (b)(4), (b)(6) and experienced a measured liner wear of 2mm or greater.No x-rays, pictures or other documents were provided.Devices analysis: devices analysis could not be performed as no product was available for investigation neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) was unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history were unknown.Adherence to rehabilitation protocol was unknown.In conclusion, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event.However, all possible causes related to the issues reported are listed in the dfmea which is available for every zimmer (b)(4) implant and is continuously monitored and updated.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: METAL HEAD
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5077396
• MDR Text Key: 25791157
• Report Number: 9613350-2015-01275
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• 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