MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD, 12/14, 32 X 0; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 11/26/2013

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

Event Description

It was reported that a patient was implanted a biolox delta head, 12/14, 32 x 0 on (b)(6) 2013.The patient was hospitalized on (b)(6) 2013 due to the hip pain, fever and increase in crp.Septic arteritis was diagnosed and on (b)(6) 2013 the patient underwent a revision surgery for removal and reinsertion of ceramic head and acetabular liner.Dr.(b)(6) evaluated that this serious adverse event was not related to the device.

Manufacturer Narrative

As per fda¿s directive, medwatch report has been resubmitted for correcting the mfr number from 9631550-2016-00054-001 to 9613350-2016-00054-001.All the information captured as per 9631550-2016-00054-001 including g4(date received by manufacturer) except b4.Additional: h2.Update: g4, g7, h6, h10.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend is 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 is reported that patient received a biolox delta head and unknown liner on (b)(6)2013.And were revised on (b)(6)2013 due to infection (septic arteritis).No x-rays, pictures, surgical notes or other documents were provided for review.No product was available for investigation.Root cause analysis: the gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected.Lot has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this product family.Therefore, it is highly unlikely that a disadvantageous product design favored or contributed to the infection.However, the appropriate ifu for endoprosthesis states that "early or late infections" are "possible consequences of an implant" and should be considered when implanting zimmer biomet devices.However, all possible causes related to the issues reported are listed in the appropriate 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.Zimmer's reference number of this file is (b)(4).

Event Description

The patient was implanted on right side and revised due to pain, fever and increase in crp.

• Brand Name: BIOLOX DELTA HEAD, 12/14, 32 X 0
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 5376203
• MDR Text Key: 36237265
• Report Number: 9613350-2016-00054
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2695654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: 03/17/2016
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR