MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is pending.The device history records were reviewed and found to be conforming.Intraoperative pictures, if available, were requested at complainant.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

It is reported that a patient underwent a primary surgery with a biolox® delta, ceramic femoral head, s, 32/- 3.5, taper 12/14 on (b)(6) 2017 on unknown hip side.During functional testing reduction, the head was found too short.Intra-operatively, head was not able to remove as it was well stuck together with stem.Thus head along with stem was exchanged intra-operatively.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: during the trend analysis, no trend was identified.Review of event description: patient underwent primary surgery with brexis stem - biolox delta head on (b)(6), 2017.During functional testing reduction, the head was found too short.Intra-operatively, head was not able to remove as it was well stuck together with stem.Thus head along with stem was exchanged intra-operatively to a cls shaft.Brexis stem is a 3rd party product which is distributed by zb winterthur.Manufacturer is stemcup medical products ag.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis visual examination: for the investigation of the case the brexis stem and biolox delta ceramic head are received as one piece together.The two components are stuck and it was not possible to remove the head from the stem.The stem has some slight bone attachments on the surface indicating that the stem was placed into the bone.The ceramic head has metallic transfer on the bottom surface which most probably happened while it was tried to be extracted from the stem.Review of product documentation - product combination is approved by zimmer biomet.The length of the original ball head is determined during operation by means of manipulating trial ball head according to brexis surgical technique.Refer to page 9 of brexis surgical technique for the detailed explanation for the trial reduction using the trial head.Root cause analysis: root cause determination using dfmea - injury of or staff or surgeon due to wrong handling of device due to wrong information => possible: the ceramic head got stuck on the stem.Conclusion summary according to the reported event the ceramic ball head got stuck on the stem taper and it led to 20 min delay of the surgery while the surgeon was not able to remove the head, thus exchanging the brexis stem by cls stem.Brexis surgical technique explains the correct surgical procedure how the length of the ceramic original implant head is determined during operation by means of trial reduction with the trial head.This ensures that there are no longitudinal discrepancies when repositioining with the original ball head.After the exact size is found by trying out with the trial head it is not intended to remove an original ball head from the original shaft.In such a process the risk of injury to the shaft is too great.It is assumed that during the surgery trial head was not used, but instead directly the originical ceramic head is placed on the stem.Subsequently, when it is realized that the size of the original head does not match, it was not possible to remove the head from the stem therefore the stem-head had to be removed and cls stem had to be placed in.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The root cause is the non-indicated use of the product.Surgeon did not follow the surgical technique.Zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, 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: 6562660
• MDR Text Key: 75010958
• Report Number: 0009613350-2017-00645
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• 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: 00-8775-032-01
• Device Lot Number: 2875836
• Other Device ID Number: 00889024430310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2016
• 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
• Patient Age: 52 YR