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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 06/29/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the explanted device for review since it was scrapped by the hospital.X-ray pictures and surgical reports were received and will be reviewed within the investigation.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.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.(b)(4).

Event Description

It was reported that the patient was implanted a biolox delta ceramic femoral head, s, 36/-3.5, taper 12/14 on (b)(6) 2015 and underwent a revision surgery on (b)(6) 2015 due to noise.The 36mm head was replaced by a 32mm head.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: it was reported that the patient underwent revision surgery of the left thr due to noise.The 36mm head was replaced by 32 size head after 3 months in vivo time.Review of received data: x-rays before/after the implantation surgery and after the revision surgery were received.X-rays in ap view dated (b)(6) 2015: it can clearly be observed that the size of the head used is much bigger compared to the liner in place on the left side.No other abnormalities were observed.X-rays in ap view dated (b)(6) 2015: it can be seen that compared to the previous x-rays, the big ceramic head is replaced by a rather smaller size ceramic head on the left side of the patient.No other abnormalities were observed.Implantation report dated (b)(6) 2015: operation: bilateral total hip arthroplasty 52mm acetabular cup, 36mm liner and 36mm ceramic head were implanted on both left and right sides.Hip was observed to be stable.After the analysis of the x-rays, revision surgery report and the implant stickers it is realized that on the left thr a 32mm liner was implanted rather than a 36mm one (typo error in the implantation report dated (b)(6) 2015) revision surgery report, dated (b)(6) 2015: operation: it is observed that instead of a 32mm size ceramic head, a 36mm size was implanted in the implantation surgery of left thr which took place on (b)(6) 2015.Therefore the head is replaced by a 32mm size head.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the ifu for biolox delta acetabular liners states that ¿acetabular cup systems intended for biolox delta ceramic-on-ceramic articulations may only be paired with the compatible femoral heads.Always ensure that the outer diameter of the femoral head matches the inner diameter of the liner." root cause determination using dfmea: - mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset, wrong taper size combination => possible: 32mm liner was combined with a 36 mm ceramic head, which is not an allowed size combination.Conclusion summary: the x-rays and the revision surgery report confirm that during the implantation surgery of the left thr a 32mm size liner was combined with a 36mm ceramic head.This size combination is not allowed by zimmer biomet.32 mm liner should have been combined with a 32 mm head.Therefore, based on the given information and the results of the investigation, we consider the root cause for this issue as user error / inappropriate combination of the product.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, 36/-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: 5814770
• MDR Text Key: 50174560
• Report Number: 0009613350-2016-01063
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-01
• Device Lot Number: 2778819
• Other Device ID Number: 00889024430358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 97