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

Catalog Number 00-8775-036-03

Device Problems Material Discolored (1170); Packaging Problem (3007)

Patient Problem No Information (3190)

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).

• Brand Name: BIOLOX DELTA CER HEAD 36 12/14
• Type of Device: BIOLOX 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 Key: 5264337
• MDR Text Key: 32618588
• Report Number: 9613350-2015-02002
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• 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 Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: 2798765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 82