MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Date 10/13/2016

Event Type  malfunction  

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

Event Description

It was reported that a biolox delta, ceramic femoral head, m, 36/0, taper 12/14 should be implanted in a surgery on (b)(6) 2016.It was also reported: "defective taper of biolox head, it would not seat." the surgery was completed with another device.

Manufacturer Narrative

Investigation results were made available.Update: date received by mfr, type of reports, if follow-up, what type?, evaluation codes, additional mfr narrative.Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description : it was reported that biolox head did not seat due to defective taper.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.The product was indicated to be returned for the investigation by the customer, however, it was not returned after several times of request.Root cause determination using dfmea: - surgeon is not able to assemble head on stem taper due to inadequate design of taper-connection - not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in or in the current pms process.- loss of connection due to inadequate assembling procedure - possible: product is not returned for investigation, therefore cannot be excluded.- loss of connection, fracture of ceramic head due to use on a damaged stem taper - possible: the combined stem is not known, therefore cannot be excluded.Conclusion summary the review of the dhr indicates that the head met all requirements to perform as intended.The product was indicated to be returned for the investigation by the customer, however, it was not returned after several times of request.Neither surgical report nor photos of the device was received.In the absence of such, a root cause analysis is not possible.Therefore , 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, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6119995
• MDR Text Key: 60623418
• Report Number: 0009613350-2016-01366
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2842511
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1