MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received the device and investigation is in progress.X-rays or other source documents were not provided for review.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.An e-mail requesting additional information (availability of the device, surgical reports, pictures, patient history, information about other involved devices) was sent on (b)(6) 2014 to the responsible person who initiated this complaint/appropriate representative.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the size of the trial head does not match with the size of the definitive implant biolox delta, ceramic femoral head, s, 40/-3.5, taper 12/14 which was of the same size as the trial head.It was reported that another head of a bigger size was used to complete the surgery.The surgery was completed with 5 minutes delay.It is a split case with zimmer (b)(6) with reference number (b)(4) (for the trial head).

Manufacturer Narrative

No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: according to the received per, the chosen ceramic head does not match with the size of the test head.As a result of that, the surgeon used a bigger size head to complete the surgery.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis - visual examination the ceramic head was received for investigation.Several scratches are visible on the articulation surface which most probably derived during implantation.Also, signs of usage in the form of scratches are visible in the inner taper which also were caused during the implantation procedure.Apart of that, no further observations can be made.- check of the ceramic head size the ceramic head is laser marked as: 40-12/14 -3.5, which matches with the article number given in the per ((b)(4)).Caliper z7568 was used to measure the outer diameter of the head.Measured dimension: specification: 40 +0, -0.065 // result: 39,98mm.
=
> within specification.Correct size of the head can be confirmed.Review of product documentation/compatibility.- review of product information: the received product information shows the following: used ceramic head: biolox® delta, ceramic femoral head, s,40/-3.5, taper 12/14.Used test head: versys femoral head prov -3.5x40mm.Hip development confirmed ,that these two components can be used together and therefore are considered "compatible".Conclusion summary: according to the received per, the chosen ceramic head does not match with the size of the test head.As a result of that, the surgeon used a bigger size head to complete the surgery.Only the ceramic head was returned to zimmer (b)(4), winterthur, as the corresponding test head (00-7895-040- 01 - versys femoral head prov -3.5x40mm) is manufactured by zimmer inc., (b)(4) (the device is reported with split case (b)(4)).The returned ceramic head shows several scratches on the articulation surface and on the inner taper, most probably caused during the implantation process.The conducted visual examination and dimension check confirmed the correct dimension and size of the ceramic head.Also, the compatibility check confirmed that the applied implant/test head combination is approved.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.The conducted complaint history shows that no further complaints with the same event were reported for the same article/lot number.That being said, no product failure could be confirmed.A possible cause might be inappropriate handling of the user during the implantation process.However, based on the given information and the conducted investigation, no specific root cause could be determined.The need for corrective measures is not indicated and 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, 40/-3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEADS
• 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: 6289505
• MDR Text Key: 66149191
• Report Number: 0009613350-2017-00185
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-01
• Device Lot Number: 2730071
• Other Device ID Number: 00889024430396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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 Outcome(s): Other