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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA CER HEAD 36 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD

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ZIMMER GMBH BIOLOX DELTA CER HEAD 36 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD Back to Search Results
Catalog Number 00-8775-036-03
Device Problems Material Discolored; Packaging Problem
Event Date 11/04/2015
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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).

 
Event Description

It was reported that the surgeon wanted to implant a biolox delta cer head 36 12/14. He noticed a grey discoloration on the device when the staff opened the package. Another device was used to complete the surgery.

 
Manufacturer Narrative

Dhr review results: biolox delta cer head 36 12/14 ref: 00-8775-036-03 lot: 2798765 yield: (b)(4). Delivered: (b)(4). Scrapped: 0. Reason for scrapping: n/a. Delivery date: 10. 07. 2015. The device manufacturing quality records indicate that the released components met all requirements to perform as intended. No trend was identified. The compatibility check could not be performed as only one product was reported to us. The product compatibility check is not relevant for one product only. Review of incoming information: it was reported that during a hip surgery the surgeon noticed an apparent gray discoloration on the implant as the surgical staff was taking it out of the package. Another device was used to complete the surgery. A photo of the biolox head taken at the hospital was received for investigation. A slightly gray coloured area was visible on the surface of biolox head. Devices analysis: the biolox delta head was received for investigation. There was no similar area as observed on in the picture with a gray coloured zone visible on the device, which implied that it was not a metallic transfer. The head showed no abnormalities. Possible causes for the reported event according to dfmea: unsterile product, damaged product -> due to inadequate packaging (eg. Temperature, vibration, impact during transport or storage). Comparison to investigation results whether it is possible and justification: possible -> the device was packaged according to specifications. However, the handling of the device is out of zimmer control. The received biolox head did not show any product damage or any reproducible alleged failure. Device history records showed that the released products were according to the specifications and no concessions were found. Moreover, the surface of the head is 100% visually inspected before it was released. It is not known what could have happened after the package was opened. Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue. The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).

 
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Brand NameBIOLOX DELTA CER HEAD 36 12/14
Type of DeviceBIOLOX DELTA CERAMIC FEMORAL HEAD
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 Key5264337
Report Number9613350-2015-02002
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number00-8775-036-03
Device LOT Number2798765
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/24/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/03/2015 Patient Sequence Number: 1
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