MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD, 12/14, 36 X -3.5; BIOLOX DELTA CERAMIC FEMORAL HEAD

Catalog Number 00-8775-036-01

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.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 patient was implanted a biolox delta head, 12/14, 36 x -3.5 in (b)(6) on (b)(6) 2014.The patient is experiencing dislocation.It was stated that no revision has been performed and the patient is being monitored.The patient is currently in usa.

Manufacturer Narrative

Dhr review: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Compatibility check: the compatibility check was performed and showed that the product combination was approved by zimmer (b)(4).Review of incoming information: it was reported that the patient received a biolox head combined with trilogy longevity pe liner on (b)(6) 2014 and is experiencing dislocations.Root cause analysis: neither x-rays, office visit notes, nor operative notes were received; therefore the condition of the component 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 dislocations.However, all possible causes related to the issues reported are listed in dfmea.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: BIOLOX DELTA HEAD, 12/14, 36 X -3.5
• 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: 5331429
• MDR Text Key: 34521900
• Report Number: 9613350-2015-02093
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 00-8775-036-01
• Device Lot Number: 2736065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2013
• 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